Guidant Defibrillator Recall Information

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What is an implanted defibrillator?

An implantable defibrillator is an electronic device implanted in the body and intended to prevent cardiac arrest from severe ventricular tachycardia. An electrode is connected between the heart and a tiny computer in the defibrillator. The computer monitors the heartbeat, and if it detects an arrhythmia, it activates a built-in pacemaker to restabilize the heart's rhythm. If that fails, it delivers a small defibrillating electrical jolt to the heart. In an extreme case, it resorts to a far stronger jolt to reset the heart rate.

Who is Guidant?

Guidant refers to itself as a world leader in the design and development of cardiovascular medical products. It is a major manufacturer of implantable medical devices, including defibrillators. Its corporate headquarters are in Indianapolis, with major operations in California, Minnesota, Texas, Washington, Puerto Rick and Ireland. Guidant is in the process of being acquired by Johnson and Johnson which has its headquarters in New Jersey.

What is the problem with Guidant defibrillators?

On June 17, 2005, Guidant announced that it was recalling 50,000 of its implantable defibrillators, 38,000 of which are in use in the United States. The defibrillators can short-circuit, causing them to fail and not work as intended. The company has received reports of the device malfunctioning at least 45 times, causing at least two deaths. 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.

What models are defective?

• Contak Renewal (Model H135), manufactured on or before August 26, 2004.
• Contak Renewal 2 (Model H155) CRT-Ds, manufactured on or before August 26, 2004.
• Ventak Prizm 2 DR (Model 1861), manufactured on or before April 16, 2002.
• Ventak Prizm AVT
  
• Vitality AVT
  
• Renewal 3 AVT
  
• Renewal 4 AVT
  

Who has a claim?

1. Anyone with one of the models listed above that failed, resulting in uncontrolled ventricular tachycardia requiring documented medical care, who survived the incident, has a claim for injuries and a claim for the cost of taking out the defective defibrillator, the cost of replacement, and the cost of implanting the replacement.

2. The family of a person with one of the models listed above that failed resulting in death, has a claim for wrongful death.

3. A person with one of the models above that has not failed, has a claim for the cost of taking out the defective defibrillator, the cost of replacement, and the cost of implanting the replacement.