FDAOctober 1, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for distal tip dislodgement or separation.
What to do
FDA enforcement status: Ongoing
Brands named
cordis
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 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.2023-11-28
- 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
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