Cordis Corporation: 39 FDA recall reports
Every medical device recall the FDA has published for Cordis Corporation. The fault, and how the agency graded it.
39Reports
7Class I
6Ongoing
2021-11-24Most recent
7 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.
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation
Z-0218-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 26 units
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation
Z-0220-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 4 units
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation
Z-0221-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 4 units
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of
Z-0219-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 4 units
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of
Z-0216-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 9 units
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation
Z-0217-2022 · Class II · reported 2021-11-24 · Ongoing
- Why it was recalled
- There is a potential for distal tip dislodgement or separation.
- Product
- SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- How much
- 3 units
Class I
Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
Z-2428-2021 · Class I · reported 2021-09-22 · Terminated
- Why it was recalled
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Product
- Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- How much
- 45 units
Class I
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
Z-2432-2021 · Class I · reported 2021-09-22 · Terminated
- Why it was recalled
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Product
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- How much
- 26025 units
Class I
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
Z-2431-2021 · Class I · reported 2021-09-22 · Terminated
- Why it was recalled
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Product
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- How much
- 71330 units
Class I
Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
Z-2429-2021 · Class I · reported 2021-09-22 · Terminated
- Why it was recalled
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Product
- Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- How much
- 1610 units
Class I
Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Z-2430-2021 · Class I · reported 2021-09-22 · Terminated
- Why it was recalled
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Product
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- How much
- 18730 units
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Z-2235-2021 · Class II · reported 2021-08-18 · Terminated
- Why it was recalled
- The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
- Product
- Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
- How much
- 8 units
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures re
Z-2079-2021 · Class II · reported 2021-07-21 · Terminated
- Why it was recalled
- The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
- Product
- Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
- How much
- 680 units
Class I
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC063
Z-1257-2021 · Class I · reported 2021-03-24 · Completed
- Why it was recalled
- Distal tip may become separated from the lumen wire in specific lots.
- Product
- PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
- Where it went
- US (except MT and NM) and Taiwan
- How much
- 18218 units
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Z-1477-2020 · Class II · reported 2020-03-18 · Terminated
- Why it was recalled
- Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
- Product
- Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
- Where it went
- US and UK
- How much
- 89 units
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Z-0250-2020 · Class II · reported 2019-11-06 · Terminated
- Why it was recalled
- Product was manufactured utilizing an expired inner body.
- Product
- Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
- Where it went
- US distribution to AL, AZ, FL, MN, and MO
- How much
- 21 units
Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use
Z-1198-2019 · Class III · reported 2019-04-24 · Terminated
- Why it was recalled
- Frayed pieces of the mounting card being inside the primary packaging.
- Product
- Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada
- How much
- 23481
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral
Z-0390-2019 · Class II · reported 2018-11-14 · Terminated
- Why it was recalled
- Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- Where it went
- Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.
- How much
- 162 units total (74 units in USA)
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malig
Z-0324-2018 · Class II · reported 2018-01-17 · Terminated
- Why it was recalled
- Potential for cracked luer hubs
- Product
- Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
- Where it went
- Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.
- How much
- 511
Cordis S.M.A.R.T. Flex Vascular Stent System
Z-1826-2017 · Class II · reported 2017-04-26 · Terminated
- Why it was recalled
- Deployment Difficulty.
- Product
- Cordis S.M.A.R.T. Flex Vascular Stent System
- Where it went
- FOREIGN ONLY: ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, IRAN, ISRAEL, ITALY, JORDAN, KOREA (South), KUWAIT, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, POLAND, PORTUGAL, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED KINGDOM
- How much
- 2,700
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Z-1947-2016 · Class II · reported 2016-06-22 · Terminated
- Why it was recalled
- Inability to deploy the stent or partial stent deployment.
- Product
- Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
- Where it went
- NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
- How much
- 4,400 units in US; 3,100 units to Foreign Countries
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
Z-1946-2016 · Class II · reported 2016-06-22 · Terminated
- Why it was recalled
- Inability to deploy the stent or partial stent deployment.
- Product
- Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
- Where it went
- NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
- How much
- 4,400 units in US and 3,100 units in Foreign Countries
CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) a
Z-1174-2016 · Class II · reported 2016-03-23 · Terminated
- Why it was recalled
- Incorrect cannula of the sheath introducer (smaller than intended).
- Product
- CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
- Where it went
- US Nationwide Distribution including states of:AL, AZ, CA, CO, CT, FL, GA, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NJ,NY, OH, OR, PA, RI, TN, TX, VA, WA, WV, and Hawaii.
- How much
- 1,985 units
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant
Z-2405-2015 · Class II · reported 2015-08-26 · Terminated
- Why it was recalled
- Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.
- Product
- RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
- Where it went
- Distributed in Germany only.
- How much
- 98 units
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, p
Z-0998-2015 · Class II · reported 2015-01-28 · Terminated
- Why it was recalled
- One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
- Product
- Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- Where it went
- Nationwide Distribution: US including states of: CT, NJ, NY, PA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, SD, IL, MO, KS, NE, LA, OK, TX, CO, UT, AZ, CA, OR, WA, AR, IN, MN, WY, ND, NV, MA, RI, NH, CT, DE, District of Columbia and Hawaii.
- How much
- 120
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Z-2556-2014 · Class II · reported 2014-09-03 · Terminated
- Why it was recalled
- The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
- Product
- Cordis EMPIRA NC RX PTCA Dilatation Catheter
- Where it went
- Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
- How much
- 250,000 units
Cordis EMPIRA RX PTCA Dilatation Catheter
Z-2557-2014 · Class II · reported 2014-09-03 · Terminated
- Why it was recalled
- The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
- Product
- Cordis EMPIRA RX PTCA Dilatation Catheter
- Where it went
- Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
- How much
- 250,000 units.
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Z-1784-2014 · Class II · reported 2014-06-18 · Terminated
- Why it was recalled
- Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
- Product
- Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
- Where it went
- Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.
- How much
- 80 units
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE)
Z-0081-2014 · Class II · reported 2013-11-06 · Terminated
- Why it was recalled
- Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter.
- Product
- Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.
- Where it went
- Worldwide Distribution - US (nationwide) including Hawaii and Puerto Rico and states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries of: Canada and Panama.
- How much
- 29,395 units
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or d
Z-0003-2014 · Class II · reported 2013-10-09 · Terminated
- Why it was recalled
- Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
- Product
- Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
- Where it went
- Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
- How much
- 1238 units
Showing the 30 most recent of 39. 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.
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