Edwards Lifesciences, LLC Recalls
7 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (7)
- Class II
March 27, 2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Class I
May 14, 2025
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
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
May 14, 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
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
May 14, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
May 14, 2025
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
May 14, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- Class I
May 14, 2025
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
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