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Guidant Defibrillator Recall List

Did You Know?
According to Guidant, the devices have reportedly failed at least 45 times and have caused at least two deaths as recently as May 30, 2005.

On June 17, 2005, Guidant Corporation recalled its cardiac defibrillators implanted in 50,000 patients around the world due to potentially fatal malfunctions of the devices. There are approximately 38,000 patients in the United States with Guidant brand defibrillators, which reports indicate have failed 45 times and are responsible for at least two deaths since May 30, 2005.

Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.

The recall came shortly after Guidant issued a safety advisory to physicians concerning its heart defibrillator, reportedly after the company learned an article by the New York Times was being prepared. The New York Times reported that Guidant did not tell doctors or patients for three years that the device contains a flaw that has caused a small number of defibrillators to short-circuit and stop working.

On July 1, 2005, the FDA classified the recall of certain Guidant defibrillator models as a Class 1 recall, the most serious level of product recall.

Guidant recalled the following models of cardiac defibrillators:

Classifications can fall into three categories, with Class I being the most serious. These numerical classifications are based on the probability that the device failure could lead to adverse health effects.

Class I (most serious) recall: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.)

Class II (any injury caused by a malfunction should be temporary or reversible) recall: Guidant models Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF.

First Recall Replacement, June 17 2005

Manufactured on or before August 26, 2004.

First Recall Reprogramming June 17, 2005

Second Recall Replacement; June 23, 2005
All serial numbers of CONTAK RENEWAL 3 and 4 , RENEWAL 3 and 4 AVT , and RENEWAL RF .

 Third Recall Replacement; July 18, 2005

If you are in need of legal advice about your Guidant Defibrillator or Guidant Pacemaker, or simply wish to speak to an attorney who has experience with Guidant Recall in your state, you may use our Free Online Consultation Form.

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