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FDA & Regulatory

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

Event Type

All EventsRecallPMA ApprovalAdverse Event

Company

All CompaniesABBOTT MEDICALAbbott MedicalCardinal HealthCardinal Health 200, LLCCryolife IncEdwards Lifesciences, LLCLifeNetMedtronic, Inc.Occlutech Holding AGW. L. Gore & Associates, Inc.
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2 events
PMA ApprovalApr 9, 2026
PMA undefined: Avalus Bioprosthesis

Company: Medtronic, Inc.

— Applicant: Medtronic, Inc.

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

Company: Medtronic, Inc.

— Applicant: Medtronic, Inc.