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Guidant Pacemaker | Defibrillator Recall News Article
 
June 17, 2005
Associated Press, "FDA recalls Guidant heart defibrillators; More than 38,000 implanted devices could malfunction"
          The U.S. Food and Drug Administration will recall more than 38,000 faulty cardiac defibrillators implanted in patients because of potential malfunctions in the devices, the manufacturer Guidant Corp. said Friday.
          Indianapolis-based Guidant said it was voluntarily advising physicians about the safety of several defibrillator models and that regulators had indicated the move would be classified as a recall.
          The devices have failed at least 45 times and have caused at least two deaths as recently as May 30, the company said. Guidant came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.
          Friday’s recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
          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.

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