June 17 , 2005—Guidant Corporation announced a recall of
nearly 50,000 heart defibrillator medical devices, including the Ventak
Prizm 2 DR, Contak
Renewal 1 and 2, Ventak Prizm AVT, Vitality
AVT, and Renewal 3 and 4 AVT.
Guidant has indicated it would replace approximately 28,900 of the devices already implanted in
patients. An additional 21,000 devices can be corrected by external reprogramming.
The subject devices are attributed to at least 45 failures, including seven deaths.
Patients who have been implanted with one of the devices are urged to consult their physician to
discuss the benefits and risks of removing the potentially defective devices. |