FDA & Regulatory

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

12 events
PMA ApprovalJun 22, 2026
FDA PMA: Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves

Company: ABBOTT MEDICAL

— Applicant: ABBOTT MEDICAL

PMA ApprovalJun 11, 2026
FDA PMA: Masters Series™ Aortic Valved Graft with Hemashield™ Graft Technology (CAVGJ)

Company: ABBOTT MEDICAL

— Applicant: ABBOTT MEDICAL

PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM PFO Occluder; AmplatzerTM Talisman™ PFO Occluder

Company: ABBOTT MEDICAL

— Applicant: ABBOTT MEDICAL

PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM Muscular VSD Occluder

Company: ABBOTT MEDICAL

— Applicant: ABBOTT MEDICAL

PMA ApprovalMay 28, 2026
FDA PMA: AmplatzerTM Septal Occluder; AmplatzerTM Multifenestrated Septal Occluder - Cribriform

Company: ABBOTT MEDICAL

— Applicant: ABBOTT MEDICAL

PMA ApprovalMay 11, 2026
PMA undefined: Occlutech Pistol Pusher

Company: Occlutech Holding AG

— Applicant: Occlutech Holding AG

PMA ApprovalMay 8, 2026
PMA undefined: GORE® CARDIOFORM Septal Occluder

Company: W. L. Gore & Associates, Inc.

— Applicant: W. L. Gore & Associates, Inc.

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 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 9, 2026
PMA undefined: Avalus Bioprosthesis

Company: Medtronic, Inc.

— Applicant: Medtronic, Inc.

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

PMA ApprovalMar 3, 2026
PMA undefined: Mosaic Neo Mitral Bioprosthesis

Company: Medtronic, Inc.

— Applicant: Medtronic, Inc.