Abbott recalls Heartmate 3 LVAS after 70 injuries, 2 deaths reported

FDA says that Abbott's HeartMate 3 Left Ventricular Assist System (LVAS) implant kit is under class I recall following 81 incidents of blood leakage and air entry, including 71 injuries and 2 deaths. This recall is a correction, not a product removal; Abbott is updating the instructions for use after complaint reviews identified blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff that may cause serious injuries or death. In all reported events, the issue was observed during implantation of the device.