Guidant Warns About Heart Implant Devices

Guidant Corporation announced June 22 that it voluntarily advised physicians that some of their devices are "subject to a component failure". The company stated that it had apprised the U.S. Food and Drug Administration of this action, and that the FDS may classify Guidant's action as a recall.

The company advised physicians to stop using the following devices manufactured by the company:

Contak Renewal 3, Contak Renewal 4, Renewal 3, 4 AVT and Renewal RF

Guidant issued a stated stating that "a magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the devices ability..." The company also stated that it was aware of four cases of a device malfunction out of 46,000 implants. The company also is investigating a fifth occurrence. At this time, device replacement has been the only consumer patient impact according to the company.

Guidant Corporation is due to be acquired by Johnson & Johnson, but saw its stock battered after the announcement, falling below its 20 month average in the first day of trading after the announcement.

The first warning from Guidant about problems with its devices was reported at Consumer Help Web last month

posted by Consumer Help Web Editorial Team at 7:25 PM |