Edwards Lifesciences, LLC is recalling approximately 61,708 Optisite Arterial Cannulae and FEM-FLEX II Femoral Arterial Cannulae due to reports of a 3mm to 4mm section of wire protruding from the outside of the device body. These devices are used in cardiac surgery to provide blood flow for up to 6 hours. The recall includes multiple models (OPTI16, OPTI18, FEMII016A, FEMII016AS, FEMII018A, and FEMII018AS) manufactured in the United States and distributed worldwide.
A protruding wire on the cannula body can cause injury to blood vessels or surrounding tissue during insertion or use. It may also damage the extracorporeal circuit or compromise the sterile field during surgical procedures.
All lots up to BSLC9149.
All lots up to BSLC9155.
All lots up to BSLC8179.
All lots up to BSLC1689.
All lots up to BSLC9148.
All lots up to BSLC9064.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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