HeartWare recalls HVAD controller used in patients with heart condition

HeartWare is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump’s driveline connector to become separated from the front portion of the driveline connector.

A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death, FDA MedWatch explained.

This recall is for products with serial numbers: HW001 to HW11270, and HW20001 to HW 20296 manufactured in period March 6, 2006 to October 17, 2016.

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. The HVAD is designed for use both in and out of hospital settings, including during patient transport.