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Guidant Recalls Dangerous Defibrillators

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Yesterday, an announcement was made that Guidant Corp. is recalling several types of cardiac defibrillators, which are implanted in nearly 50,000 people around the world.

The United States Food and Drug Administration (FDA) said that Guidant is voluntarily recalling the defibrillators which are now considered to be dangerous.

The defibrillators have flaws that can lead to their malfunction, which can lead to the death of the person who has it implanted inside of them. At least two people with the defibrillators have died so far.

Guidant Recalls Dangerous Defibrillators

“Patient safety is paramount and our highest priority,” stated Guidant President and CEO Ronald W. Dollens. “As a leading manufacturer of lifesaving technology, Guidant takes seriously its responsibility to create the most reliable products and services, enhance patient outcomes and limit adverse events to patients.”

Doctors are being advised about the safety of three models of defibrillators by Guidant. There have been 45 cases in which the devices have failed.

The defibrillator models being recalled include:

  • VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002.
  • CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004.
  • VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers).
  • “The purpose of the company’s recent communications is to share information with physicians and patients about problems in a small subset of Guidant devices,” said Dollens. “We will work with physicians as they decide how best to treat their patients.”

    Dollens added, “Guidant is committed to establishing industry guidelines and processes to determine when, how and under what circumstances adverse events should be communicated to doctors and patients. Guidant hopes to work with FDA, other regulatory agencies and physicians to convene a panel to assist the medical device industry in establishing clear guidelines.”

    Yesterday MarketWatch reported that Guidant shares fell 92 cents, or 1.3%, to $72.74. Guidant is being acquired by Johnson & Johnson, which was up 18 cents to $66.48.

    Chris is a staff writer for WebProNews. Visit WebProNews for the latest ebusiness news.

    Guidant Recalls Dangerous Defibrillators
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