FDA Update: Heartmate II and Heartmate 3 LVAS Recalled Due to Obstruction – American College of Cardiology
The U.S. Food and Drug Administration (FDA) announced on April 15 that Abbott/Thoratec Corp. is recalling the Heartmate II and Heartmate 3 Left Ventricular Assist System (LVAS) due to long-term buildup of biological material causing an obstruction in the device, making it more difficult for the heart to pump blood. According to the agency, “The Heartmate II and 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure … Heartmate 3 can also be used in