The FDA posted on its website a Class I recall of Abbott’s HeartMate 3 Left Ventricular Assist System Implant Kit. The HeartMate 3 Left Ventricular Assist System is used to help the heart pump blood when it is not able to do so effectively on its own. Abbott is recalling the HeartMate 3 LVAS after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff, the FDA said. Abbott reports 81 incidents, including 70 injuries and two deaths related to this issue.
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