CURATED FOR THE STRUCTURAL HEART COMMUNITY

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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.

1 events

RecallMay 25, 2026

Recall: Pulmonary heart valve allograft, human tissue for transplantation.

Company: LifeNet

Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.