A small mechanical heart pump manufactured by Thoratec Corporation has been recalled after 5 deaths were reported. The affected catalog numbers are 1355 and 102139. The heart pumps have been distributed to 153 hospitals throughout the country since the beginning of clinical studies in 2003.
The HeartMateII pump was approved in April for the temporary treatment of patients awaiting heart transplants. The recall was prompted by a failed electrical wire in the heart pump. The failure occurred in 27 of the 1,972 people who were using the heart pump device. In June 2007, Thoratec began using a stronger, more durable wire that has shown a lower failure rate.
Thoratec has recommended that patients using the heart pump device consult with their physician to determine the condition of the electrical wire.