Batteries used in the HeartWare Ventricular Assist Device (HVAD) are being recalled because they may have faulty cells causing them to lose power prematurely. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating low battery level, the pump will stop working and the patient may experience serious adverse health consequences, including death, the Food and Drug Administration (FDA) warned.
The recall includes batteries used on HeartWare Ventricular Assist Device (HVAD) with the Serial numbers BAT000001 to BAT199999, Model number 1650, manufacturing dates: May 19, 2013 to July 1, 2015 and distribution dates: May 21, 2013 to July 31, 2015. A total of 18,631 units were recalled nationwide, including Washington D.C.
The HVAD helps deliver blood from the heart to the rest of the body in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart, called the pericardium, and a controller that controls the speed and function of the pump.
HeartWare sent an “Urgent Medical Device Recall” letter to its customers instructing them to identify and quarantine affected batteries under patients’ possession and in hospitals.
Patients and health care professionals should report any adverse events or quality issues with HeartWare Ventricular Assist Devices or any of their components to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.