Thoratec Recalls HeartMate II Pumps Over Deaths

Pleasanton, CA (AHN) - Thoratec Corporation of California ordered the recall of batches of a small mechanical heart pump after five people with the implants died.

The company recalled batches of Heartmate II pumps with catalogue numbers 1355 and 102139, distributed throughout 153 hospitals and dealers across the country and overseas since the pharmaceutical firm started clinical studies on the device beginning November 2003.

The company, through a statement, encouraged patients to have their implants checked after it was discovered there were 27 incidents of wear and tear fatigue on the device's electrical wires which needed replacement.

The findings were based on a five-year observation period of almost 2,000 implant patients in which five died because the device could not be replaced.

The HeartMate II was designed as a temporary treatment for patients who are waiting for heart transplants or patients with end-stage heart failure and too sick to undergo surgery.