Cordis US Corp
20 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cordis US Corp and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-09FDA-DeviceClass IICordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
- 2025-04-09FDA-DeviceClass IICordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
- 2025-03-19FDA-DeviceClass IIVista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Catheter manufactured at the incorrect length.
- 2024-01-17FDA-DeviceClass IIMYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
- 2024-01-17FDA-DeviceClass IIMYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
- 2023-11-15FDA-DeviceClass ICordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Non-sterile product labeled as sterile was distributed.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
- 2023-05-17FDA-DeviceClass IANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
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