June 20, 2005

Devicemaker Guidant is voluntarily recalling implantable defibrillators and cardiac resynchronization therapy defibrillators because the devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification are: Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002; and Contak Renewal, Model H135, and Contak Renewal 2, Model H155 -- both manufactured on or before Aug. 26, 2004.

Guidant also recently informed the FDA that it is recalling another set of defibrillator devices called Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. The FDA is continuing to look at the situation to determine whether the company disclosed the problems properly.

(http://www.fdanews.com/ddl target=_blank)