The U.S. Food and Drug Administration has issued a nationwide recall notification regarding certain implantable heart defibrillators and cardiac resynchronization defibrillators manufactured by Guidant Corporation of Indianapolis.
According to the FDA report, the following models have been shown to develop a short circuit, without warning, that can result in failure to deliver a shock to the heart when needed.
·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 be recalling another group of heart defibrillators that have shown to have memory error problems. This group includes the models known as PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT.
Reports indicated that at least 45 failures have occurred leading to at least two deaths as recently as May 2005.
Guidant said patients implanted with those devices should continue to see their doctors at three-month intervals and any patient who recently received a defibrillator shock should consult with their physician.
“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 they will continue to sell the original Prizm 2 DR heart defibrillator even though a potential flaw prompted a redesign.
In April 2005, Guidant shareholders had approved acquisition of Guidant by Johnson & Johnson. Reports indicate that merger will still happen sometime this year.
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If you or a loved one is currently using one of the recalled heart defibrillators, you may have a liability claim against Guidant Corporation. Please e-mail or call Jacoby & Meyers for an experienced defective product attorney at 1-888-JACOBY-1.