Abbott and Thoratec Recall Nearly 14,000 HeartMate Devices Due to Safety Concerns
Chicago, Illinois – The U.S. Food and Drug Administration (FDA) recently issued a Class I recall for nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and its subsidiary Thoratec. This recall comes after reports of safety issues that have tragically led to multiple deaths linked to the devices. The recall specifically affects both the HeartMate II LVAD and the HeartMate 3 LVAD due to the accumulation of biological materials within the devices. …