Edwards Lifesciences is recalling 92 units of the PASCAL Precision Transcatheter Valve Repair System (Models 20000ISM and 20000IS) due to a manufacturing defect. During heart valve repair procedures, the delivery system may experience resistance when the surgeon attempts to release the implant. This defect can require excessive force to operate, which may cause the heart implant to rotate or result in unintended positioning within the patient's mitral or tricuspid valves.
The resistance encountered during the release process can lead to the heart implant shifting or rotating unexpectedly during a critical phase of the surgery. This poses a risk of improper valve repair or internal injury during the implantation procedure.
Healthcare provider or manufacturer coordination
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.
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Sources: FDA iRES · Raw API Response
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