The U.S. Food and Drug Administration (FDA) is reporting the voluntary recall of certain models of a ventricular assist device due to serious electrical issue. It is a Class 1 recall, the most serious type possible.
Manufactured by HeartWare, Inc., the ventricular assist device is designed to help pump blood from the heart to the rest of the body, and is most often used by patients waiting for a transplant due to end-stage left ventricular heart failure. Hospitals and medical providers may also use the device to monitor patients with potential heart failure. A pump is implanted in the area around the heart to deliver blood; a controller helps to regulate the speed of the pump.
According to information released by the FDA, the driveline in the device (a tube that connects the pump to the external controller) presents a high risk of becoming contaminated. If this occurs, fluids or other materials could infiltrate into the pump, leading to certain electrical problems, or even resulting in a complete shutdown of the device and the risk of serious injury or death.
HeartWare is urging all patients who received the device between July 31, 2014 and March 30, 2016 to contact their medical provider or HeartWare directly for more information. The recall impacts 105 devices in the United States.