July 5, 2016 — HeartWare Inc. announced a recall of the batteries used on the HeartWare Ventricular Assist Device (HVAD) because the batteries may lose power prematurely due to faulty cells.
The company said 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 may experience serious adverse health consequences, including death.
The recall includes 18,631 model 1650 units in the United States, including Washington, D.C., including devices manufactured between May 19, 2013 and July 1, 2015, and distributed between May 21, 2013 and July 31, 2015. Affected serial numbers include BAT000001 to BAT199999.
The HVAD helps deliver blood from the heart to the rest of the body. It is used 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 (pericardium) and a controller that controls the speed and function of the pump.
HeartWare sent an "Urgent: Medical Device Recall" letter to affected customers on Jan. 7, 2016. The letter instructed customers to:
- Complete and return the acknowledgement form attached with the letter
- Identify and quarantine affected batteries under patients’ possession and in hospitals
- Arrange an appointment with a qualified representative for replacement batteries with improved cells
- Return the affected products to HeartWare Inc. along with the completion form attached with the letter
- Forward the notice to third affected customers
For more information: www.heartware.com