Edwards Lifesciences, LLC recalls

2 recalls on record · 1 rated Critical · FDA

Every recall we have on record for Edwards Lifesciences, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.

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Health Critical

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula …

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

Edwards Lifesciences, LLC Jul 16, 2025

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Health Serious

Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

Edwards Lifesciences, LLC Nov 15, 2023

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