Guidant Corp. issued a worldwide recall yesterday of more than 40,000 surgically implanted cardiac defibrillators because of potential malfunctions in the devices.
It's the second major defibrillator recall this year. A Medtronic Corp. recall in February has resulted in new surgeries for more than 11,000 Americans who need the device to shock their heart back into a normal rhythm once it starts beating irregularly.
The Guidant recall, however, caused mass confusion yesterday among patients and their doctors because the Indianapolis company and its sales representatives had been assuring them as recently as this week that it was not recommending replacement.
The U.S. Food and Drug Administration has been investigating increasing reports of problems with the devices. Guidant devices have failed at least 45 times and have been linked to at least two deaths, one as recently as May 30, the company said.
Guidant first came under fire this spring after reports that it failed to alert physicians about potential problems with the Ventak Prizm 2 DR model defibrillator.
The failures prompted Guidant to redesign the device, but the company said it believed the originals were reliable. As of yesterday, there have been 28 reports of failure, including one death in 26,000 devices built prior to the April 2002 redesign.
Yesterday's recall was broadened to include even more models. Those involved are: Guidant's Ventak Prizm 2 DR model 1861 manufactured on or before April 16, 2002; Contak Renewal Model H135 and Contak 2 Renewal 2 Model H155 made on or before Aug. 26, 2004; and the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.
The FDA said it is possible that patients may need surgery to replace the devices but that the decision would have to come on a case-by-case basis under consultation with doctors. Some devices might simply need testing, the FDA and Guidant said.
Guidant said it would replace the devices, which can cost $25,000, at no charge if the patient and physician decide doing so is necessary. The company did not say whether it would pay any of the surgical costs, which can run between $8,000 and $14,000 if performed on an outpatient basis.
Guidant advised patients with the device to see their doctors at three-month intervals and advised any patient who recently received a defibrillator shock to consult with his or her physician.
Guidant Chief Executive Ronald Dollens said the company would work with doctors as they decide how to best treat their patients in relation to the recall involving what he called a "small subset of Guidant devices."
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