FDA & Regulatory

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

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All Events Recall PMA Approval Adverse Event

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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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1 events

RecallMay 25, 2026

Recall: CryoValve, Pulmonary Heart Valve

Company: Cryolife Inc

Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a...