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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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1 events
RecallMay 25, 2026
Recall: Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extractio

Company: Cardinal Health 200, LLC

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).