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 pediatric patients.” The accumulation of biological material leading to extrinsic outflow graft obstruction typically occurs over two years or more. The FDA has identified this as a Class I recall, meaning that use of these devices may cause serious injury or death.

For additional information and recommendations for clinicians, visit the FDA website.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Heart Failure, United States Food and Drug Administration, ACC Advocacy