Edwards Lifesciences, LLC recalls

7 recalls on record · latest: March 27, 2026

Official U.S. recall history for Edwards Lifesciences, LLC, compiled from official government records.

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Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

March 27, 2026 · Medical device recalls Moderate risk Labeling update to provide warning if functionality of the valve replacement de…

Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Ver…

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…

Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Pr…

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…

Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Pr…

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…

Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Pr…

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…

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

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…

Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Ver…

May 14, 2025 · Medical device recalls High risk due to complaints received for 3mm to 4mm section wire exposed/protruding from…