In five years of clinical studies with 1,972 implants, wear and fatigue to an electrical wire have been reported in 27 cases, requiring the implants to be replaced. Five deaths occurred when the implant could not be replaced.
The recall affects two batches, catalog numbers 1355 and 102139, which were distributed to 153 hospitals and distributors both nationwide and internationally since November 2003. The pump was approved in April as a temporary treatment for patients awaiting heart transplants, but in the future may be used in “destination therapy,” or patients with end-stage heart failure who are too ill for a transplant.
Thoratec Corp. is urging patients to have their implants checked.