HeartWare Inc. is recalling 18,631 batteries that are used on HeartWare Ventricular Assist Devices (HVADs), which are used to deliver blood from the heart to the rest of the body. The batteries may lose power prematurely due to faulty cells. If the HVAD system is not connected to an additional power source shortly after the system sounds an alarm indicating a low battery level, the pump will stop working and the patient could experience serious adverse health consequences, including death.
The HVAD is used in patients who are at risk of death from heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the patient’s chest and a controller that controls the speed and function of the pump. The recalled devices were distributed between May 2013 and July 2015. HeartWare sent an “Urgent: Medical Device Recall” letter to affected customers with instructions for replacing the batteries.
Source: FDA
