FDA & Regulatory

Recalls, PMA approvals, and adverse events for heart valve devices

Event Type

All Events Recall PMA Approval Adverse Event

Company

All Companies ABBOTT MEDICAL Abbott Medical Cardinal Health Cardinal Health 200, LLC Cryolife Inc Edwards Lifesciences, LLC LifeNet Medtronic, Inc.Occlutech Holding AG W. L. Gore & Associates, Inc.

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4 events

RecallMay 25, 2026

Recall: Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 96

Company: Edwards Lifesciences, LLC

A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.

PMA ApprovalApr 16, 2026

PMA undefined: INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Valved Conduit

Company: Edwards Lifesciences, LLC

— Applicant: Edwards Lifesciences, LLC

PMA ApprovalApr 16, 2026

PMA undefined: Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Bioprosthesis

Company: Edwards Lifesciences, LLC

— Applicant: Edwards Lifesciences, LLC

PMA ApprovalMar 11, 2026

PMA undefined: Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process; Carpentier-Edwar

Company: Edwards Lifesciences, LLC

— Applicant: Edwards Lifesciences, LLC