Certain batches of a small mechanical heart pump have been recalled by the manufacturer, after five people died while using the device.
Thoratec Corp. of Pleasanton, Calif., urged patients with a HeartMate II pump to have their implants checked after the company said 27 had to be replaced because of wear and fatigue to an electrical wire, the Associated Press reported.
In five cases, the device could not be replaced and the patients died, the company said in a news release. The reports occurred over five years of clinical experience with 1,972 implants, the company added.
The recall affects devices with catalog numbers 1355 and 102139, which have been distributed to 153 hospitals and distributors throughout the United States and other countries since the beginning of clinical studies in November 2003.
The HeartMate II pump was approved in April as a temporary treatment for patients awaiting heart transplants, but analysts had said the larger market for the product is in "destination therapy," or patients with end-stage heart failure who are too ill for a transplant, according to AP.