Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A P…

Recall date

May 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2083-2025

FDA classification

Class I

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA…

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS 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