FDADecember 22, 2014device
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- dilat...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
What to do
FDA enforcement status: Terminated
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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