Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. — recall Z-2587-2025
U.S. FDA — Device Enforcement · United States · 2025-08-15 · Class II
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Reported risk: Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
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