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FDAMay 14, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

What to do

FDA enforcement status: Ongoing

Brands named

edwards lifesciencesedwards

UPCs

0069013031256

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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