FDA recalls Abbott's HeartMate 3 system (Class I) due to blood leakage, 70 injuries, 2 deaths.
Abbott's HeartMate 3 system has been recalled by the FDA as a Class I recall, the most serious type, due to reports of blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff during device implantation. This issue has led to 70 injuries and 2 deaths. The HeartMate 3 system is used to help the heart pump blood when it cannot do so effectively on its own.
May 15, 2024
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