Sorin Group USA, Inc.: 52 FDA recall reports
Every medical device recall the FDA has published for Sorin Group USA, Inc.. The fault, and how the agency graded it.
52Reports
0Class I
0Ongoing
2017-11-15Most recent
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.
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile devi
Z-0076-2018 · Class II · reported 2017-11-15 · Terminated
- Why it was recalled
- A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
- Product
- FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
- Where it went
- Worldwide Distribution - US (nationwide) Internationally to France and Spain
- How much
- 40 units
Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Ca
Z-2871-2017 · Class II · reported 2017-08-16 · Terminated
- Why it was recalled
- Identification of excess plastic on the tip of the cannula.
- Product
- Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Where it went
- Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.
- How much
- 105,770 units
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Z-2795-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 4 units
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Z-2784-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 98 units
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Z-2798-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
- Where it went
- Nationwide
- How much
- 1 unit
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011
Z-2788-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 733 units
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
Z-2786-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 52 units
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
Z-2785-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 524 units
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
Z-2794-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 1 unit
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
Z-2793-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 8 units
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Z-2789-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 5 units
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
Z-2796-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
- Where it went
- Nationwide
- How much
- 1 unit
NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL
Z-2797-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
- Where it went
- Nationwide
- How much
- 1 unit
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Z-2783-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 50 units
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
Z-2790-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 32 units
STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only,
Z-2791-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 1 unit
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
Z-2792-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 54 units
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
Z-2787-2017 · Class II · reported 2017-08-09 · Terminated
- Why it was recalled
- Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
- Product
- SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
- Where it went
- Nationwide
- How much
- 632 units
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Z-2775-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 120V/60 Hz
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units
STOCKERT Heater-Cooler System 3T, 230 V
Z-2771-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 230 V
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units total
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Z-2773-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 208V/60 Hz
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Z-2772-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 240V/60 Hz
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
Z-2776-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
Z-2774-2017 · Class II · reported 2017-08-02 · Terminated
- Why it was recalled
- Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
- Product
- STOCKERT Heater-Cooler System 3T, 127V/60 Hz
- Where it went
- "Domestic: AK, 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, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."
- How much
- 7,546 units
Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Val
Z-0716-2017 · Class II · reported 2016-12-14 · Terminated
- Why it was recalled
- Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
- Product
- Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
- Where it went
- Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait, Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
- How much
- 845 units
ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, Hea
Z-0682-2017 · Class II · reported 2016-12-07 · Terminated
- Why it was recalled
- On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use ( IFU ).
- Product
- ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours
- Where it went
- Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.
- How much
- 1,618 units in the US; 129 units outside of US
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interr
Z-0413-2017 · Class II · reported 2016-11-23 · Terminated
- Why it was recalled
- Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
- Product
- The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
- Where it went
- Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
- How much
- 586 programmers
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate
Z-0412-2017 · Class II · reported 2016-11-23 · Terminated
- Why it was recalled
- Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.
- Product
- The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
- Where it went
- Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
- How much
- 847 programmers
St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage:
Z-2866-2016 · Class II · reported 2016-09-28 · Terminated
- Why it was recalled
- Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.
- Product
- St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.
- How much
- 5264 Units Worldwide
Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch C
Z-2756-2016 · Class II · reported 2016-09-14 · Terminated
- Why it was recalled
- Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.
- Product
- Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect. The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip
- Where it went
- Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.
- How much
- 200 units worldwide
Showing the 30 most recent of 52. 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