FDANovember 28, 2023device
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
cordis
UPCs
10862028000403
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only2025-03-04
- FDACordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only2025-03-04
- FDAVista 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.2025-02-07
- FDAMYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites2023-11-28
- FDACordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter2023-09-26
- FDAANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM2023-03-24
- FDAANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC2023-03-24
- FDAANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC2023-03-24
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →