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By ASHLEY M. HEHER
Associated Press Writer

INDIANAPOLIS (AP) The U.S. Food and Drug Administration will recall more than 38,000 faulty cardiac defibrillators manufactured by Guidant Corp. because of potential malfunctions in the devices. The faulty devices have been implanted into patients, the company said Friday.

Indianapolis-based Guidant said Friday 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 Guidant failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.

Guidant said patients implanted with the device 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.''

FDA officials did not immediately return messages.

Implanted defibrillators shock the heart back into a normal rhythm when it starts beating irregularly. 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.

Shares of Guidant fell 80 cents, or 1.1 percent, to $72.86 in afternoon trading on the New York Stock Exchange, where they have traded in a 52-week range of $49.95 to $75.15.

Guidant shareholders in April voted overwhelmingly in favor of Johnson Johnson's planned $25.4 billion acquisition of Guidant. The merger, which still must win regulatory approval in the United States and Europe, would be the largest business deal in the 119-year history of New Brunswick, N.J.-based health care products giant J J has said it expects to complete the acquisition during the third quarter.

Johnson Johnson did not immediately return a message.

Associated Press text, photo, graphic, audio and/or video material shall not be published, broadcast, rewritten for broadcast or publication or redistributed directly or indirectly in any medium. Neither these AP material nor any portion thereof may be stored in a computer except for personal and non-commercial use. AP will not be held liable for any delays, inaccuracies, errors or omissions therefrom or in the transmission or delivery of all or any part thereof or for any damages arising from any of the foregoing.

Copyright 2005 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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