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edwards lifesciences, llc

7 recalls on record

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

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

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Edwards Lifesciences, LLC — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral

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

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Edwards Lifesciences, LLC — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral

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

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Edwards Lifesciences, LLC — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. T

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

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Edwards Lifesciences, LLC — Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial

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

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Edwards Lifesciences, LLC — Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. T

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

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Edwards Lifesciences, LLC — Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral

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