FDA Announces Recall of Heart Device Warning of ‘Serious Injuries or Death’

The U.S. Food and Drug Administration (FDA) announced the recall of Abbott’s HeartMate 3 system after two deaths and dozens of injuries were reported, noting that “serious injuries or death” could be associated with the heart device. The current recall is the second one announced by the FDA for the HeartMate 3 left ventricular assist device implant kits. The agency also announced a previous recall for Abbott’s HeartMate Touch System. Abbott said it is recalling the HeartMate 3 products “after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device inflow cannula and the apical cuff....