Guidant Defibrillator Recalls
Recently allegations were brought against Guidant Corporation in connection with the Ventak Prizm Automatic Implantable CardioDefibrillator. This medical device is implanted in a patient's chest to control spontaneous and induced ventricular arrhythmias (irregular and rapid heartbeats). Electrodes are inserted in the heart to distinguish between regular and irregular heartbeat; when the device detects an irregularity, it delivers a powerful electric charge to return the heartbeat to normal.

Guidant came under fire earlier this spring after reports that it had failed to alert physicians about potential problems with one of the defibrillator models, the Ventak Prizm 2 DR. A 21-year-old Minnesota college student died in March when his defibrillator short-circuited while he was mountain-biking in Utah. A second death has been linked to another model.

  • The recall includes about 38,000 devices used by patients in the United States.

  • Guidant Corp. failed to inform doctors or patients for three years that one of its defibrillators, the Ventak Prizm 2, had an electrical flaw that caused some of the devices made before 2003 to short-circuit and malfunction.

  • Guidant Corp. announced it is voluntarily recalling about 50,000 of the company's defibrillators, including 38,000 in use in the United States. The company said the devices have malfunctioned at least 45 times, causing two deaths.
Models Being Recalled
  • Ventak Prizm 2 DR (Model 1861), manufactured on or before April 16, 2002.
  • Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT, Renewal 4 AVT (all series numbers).
  • Contak Renewal (Model H135) and Contak Renewal 2 (Model H155) CRT-Ds, manufactured on or before Aug. 26, 2004.

    Controversy surrounds Guidant's Ventak Prizm 2 defibrillators because of potentially fatal defects. Guidant has already been criminally charged for not warning consumers and doctors of fatal defects in their Ancure® Endograft® System, an abdominal aortic aneurysm (AAA) stent pulled from the market in 2002.

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