A medical device company has recalled certain batches of a small mechanical heart pump after five people died while using the device. Thoratec Corp. urged patients to have their implants checked after confirming 27 reports of cases in which wear and fatigue to an electrical wire required the devices to be replaced. The reports occurred over five years of clinical experience with 1,972 implants, according to the company. In five cases, the device could not be replaced and the patients died. 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.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.