10:41 AM EDT, 05/15/2024 (MT Newswires) -- Abbott Laboratories ( ABT ) is recalling its HeartMate 3 Left Ventricular Assist System Implant Kit due to risk of blood leakage or air entering between inflow cannula and apical cuff, the US Food and Drug Administration said Wednesday.
The recall covers 882 devices in the US distributed from March 1, 2021, to present, the FDA said. The implant kit assists the heart in pumping blood when it cannot do so effectively on its own.
Abbott has reported 81 incidents related to this issue, which include 70 injuries and two deaths, according to the FDA.
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