Guidant Corporation

A worldwide recall was announced by Guidant Corporation for nearly 50,000 of their heart defibrillators due to potential failures in these devices. Although the Food and Drug Administration U.S. not require Guidant to take this step, the FDA has stated that fully supports the decision because of the severity of potential defects. In particular, cardiac defibrillators, Guidant Corporation have demonstrated a trend toward short. This means that the device may not provide a shock to the heart when needed to regulate heartbeat. Reports indicate that at least 45 heart defibrillators have malfunctioned leading to at least 2 days in May 2005. Models that was recalled by Guidant Corporation include: Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002 Contak Renewal, Model H135, manufactured on or before August 26, 2004 Contak Renewal 2, Model H155, manufactured on or before August 26, 2004 In addition, the FDA announced that Guidant would also recall another group cardiac defibrillators that have demonstrated problems of memory error.

This group includes the models known as Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. “Patient safety is paramount and our highest priority,” Guidant CEO Ronald W. Dollens, said in a statement. “Guidant takes seriously its responsibility to create more reliable products and services, improve patient outcomes and limit adverse events to patients.” Guidant also said it will continue selling the Prizm 2 DR defibrillator original, despite a redesign done after discovering a potential defect in 2002. .