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Codman & Shurtleff, Inc.
Codman & Shurtleff, Inc.: 59 FDA recall reports
Every medical device recall the FDA has published for Codman & Shurtleff, Inc.. The fault, and how the agency graded it.
59Reports
12Class I
0Ongoing
2019-08-21Most recent
12 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Z-2280-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Incorrect coil length on the label
- Product
- GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
- Where it went
- Japan
- How much
- 28 units
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow I
Z-1684-2015 · Class II · reported 2015-06-03 · Terminated
- Why it was recalled
- Needle is leaking from hub/needle cannula connection
- Product
- CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .
- Where it went
- Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
- How much
- 5463 units
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indica
Z-0091-2015 · Class II · reported 2014-10-29 · Terminated
- Why it was recalled
- tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- Product
- Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
- How much
- 1145 units
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 I
Z-0090-2015 · Class II · reported 2014-10-29 · Terminated
- Why it was recalled
- tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- Product
- Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
- How much
- 93,558 units
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 In
Z-0089-2015 · Class II · reported 2014-10-29 · Terminated
- Why it was recalled
- tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
- Product
- Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
- Where it went
- Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
- How much
- 66,120 units
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Progr
Z-2188-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an impla
Z-2184-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 T
Z-2190-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product
Z-2191-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Progr
Z-2185-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The
Z-2189-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Cer
Z-2186-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The
Z-2187-2014 · Class II · reported 2014-08-20 · Terminated
- Why it was recalled
- To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
- Product
- Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
- Where it went
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- How much
- 9,498 devices total
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is inten
Z-1571-2014 · Class II · reported 2014-05-21 · Terminated
- Why it was recalled
- A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
- Product
- MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
- Where it went
- Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
- How much
- 90
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is inten
Z-1572-2014 · Class II · reported 2014-05-21 · Terminated
- Why it was recalled
- A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
- Product
- MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
- Where it went
- Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
- How much
- 34
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve O
Z-1468-2014 · Class II · reported 2014-04-23 · Terminated
- Why it was recalled
- Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
- Product
- CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System
- Where it went
- Nationwide Distribution.
- How much
- 9,445 units
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code:
Z-0860-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 431 units
Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Co
Z-0863-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 409 units
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Access
Z-0864-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 746 units
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code
Z-0862-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 369 units
Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product
Z-0861-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 1481 units
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Produ
Z-0859-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 895 units
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERT
Z-0858-2014 · Class II · reported 2014-02-05 · Terminated
- Why it was recalled
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- Product
- Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- How much
- 1460 units
Class I
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiod
Z-0789-2014 · Class I · reported 2014-01-29 · Terminated
- Why it was recalled
- Incorrect instructions for use (IFU).
- Product
- TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
- How much
- 7,983
Class I
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethio
Z-0788-2014 · Class I · reported 2014-01-29 · Terminated
- Why it was recalled
- Incorrect instructions for use (IFU).
- Product
- TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
- Where it went
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
- How much
- 3,860
Class I
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is inte
Z-2300-2013 · Class I · reported 2013-10-09 · Terminated
- Why it was recalled
- Drug flow rates exceeding programmed flow rates.
- Product
- MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- How much
- 735 units
Class I
MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intr
Z-2295-2013 · Class I · reported 2013-10-09 · Terminated
- Why it was recalled
- Drug flow rates exceeding programmed flow rates.
- Product
- MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- How much
- 5 units
Class I
MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the i
Z-2294-2013 · Class I · reported 2013-10-09 · Terminated
- Why it was recalled
- Drug flow rates exceeding programmed flow rates.
- Product
- MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- How much
- 5 units
Class I
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended fo
Z-2298-2013 · Class I · reported 2013-10-09 · Terminated
- Why it was recalled
- Drug flow rates exceeding programmed flow rates.
- Product
- MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- How much
- 0 - product used for internal training purposes only
Class I
MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended f
Z-2293-2013 · Class I · reported 2013-10-09 · Terminated
- Why it was recalled
- Drug flow rates exceeding programmed flow rates.
- Product
- MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- How much
- 2 units
Showing the 30 most recent of 59. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls