FDA Recalls Abbott and Thoratec HeartMate LVADs Due to Safety Concerns
Washington, D.C. – The U.S. Food and Drug Administration (FDA) has issued a Class I recall alerting the public about the safety risks associated with Abbott and Thoratec’s HeartMate left ventricular assist devices (LVADs). Nearly 14,000 devices are being recalled due to concerns over the gradual buildup of biological materials within the devices, which can lead to serious health complications and, in some cases, fatal outcomes. The FDA’s announcement follows reports of 14 deaths and …