Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2084-2025 — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

U.S. FDA — Device Enforcement · United States · 2025-05-14 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2084-2025
Date of alert
2025-05-14
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0069013031256
Reported risk: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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