FDA Issues Class I Recall for Abbott’s HeartMate LVADs Due to Safety Concerns
WASHINGTON, DC – The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and Thoratec due to safety concerns that have been linked to multiple deaths. According to the FDA, the recall includes both the HeartMate II LVAD and HeartMate 3 LVAD devices, with the main issue being the gradual buildup of biological materials within the devices. This buildup can …