Guidant Corporation Recalls Heart Defibrillators
A worldwide recall was announced by Guidant Corporation for nearly 50,000 of their heart defibrillators due to potential malfunctions in these devices.
Although the U. S. Food and Drug Administration did not require Guidant to take this step, the FDA has stated that they completely support the decision due to the serious nature of the potential defect.
Specifically, the Guidant Corporation heart defibrillators have been shown to have a tendency toward short-circuiting. This means that it is possible for the device to not provide a shock to the heart when needed to regulate the heart rhythm. Reports indicate that at least 45 heart defibrillators have malfunctioned leading to at least 2 days since May 2005.
· 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
"Patient safety is paramount and our highest priority," Guidant CEO Ronald W. Dollens said in a statement. "Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcome and limit adverse events to patients." They also stated that Guidant will continue to sell the original Prizm 2 DR heart defibrillator in spite of a redesign done after discovering a potential flaw in 2002.