FDA Issues Recall for Abbott’s HeartMate Devices Due to Safety Concerns Resulting in Deaths
Washington, D.C. – The U.S. Food and Drug Administration (FDA) issued a Class I recall on nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and Thoratec, citing safety concerns that have led to multiple deaths. The recall includes both the HeartMate II LVAD and HeartMate 3 LVAD due to the gradual buildup … Read more