Guidant Recalls Heart Implants

Pacemaker and Defibrillator Models Recalled

Gillin, Jacobson, Ellis & Larsen is currently representing clients implanted with defective heart defibrillators and pacemakers manufactured by Guidant Corporation.

On June 17, 2005, Guidant Corporation announced a recall of nearly 50,000 heart defibrillator devices implanted in patients, including the Ventak Prizm 2 DR, Contak Renewal 1 and 2, Ventak Prizm AVT, Vitality AVT, and Renewal 3 and 4 AVT.

There have been reports of a number of failures and deaths.

On June 24, Guidant warned about the possibility of failure in approximately 46,000 additional devices, including the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and the Renewal RF.

On July 1, the United States Food and Drug Administration classified 11 of the recalled defibrillator models. Some of the models were classified as Class 1 - the most serious classification under FDA guidelines, indicating that there is a reasonable probability that a malfunctioning device will lead to serious adverse health consequences or death.

Guidant Learned of Problems in Ventak Prizm Defibrillator But Continued Selling Defective Device

In May 2005, Guidant Corp. informed doctors that an electrical flaw in its Ventak Prizm 2 DR led to a number of failures. The problem caused some devices to short-circuit, rendering them inoperable.

Although Guidant redesigned the device in 2002 to correct the problem, the company admitted that it continued selling the original devices made prior to the design change.

Pacemakers Recalled

On July 18, one month after announcing a recall of its defibrillators, Guidant recalled more than 28,000 pacemakers. Recalled models included the Pulsar, Pulsar MAX, and Pulsar MAX II, Discovery and Discovery II, Meridian, Contak TR, Virtus Plus II, and Intelis II.

As was the case with the defibrillator recall, Guidant received reports of a number of failures and deaths.

On July 22, the FDA classified Guidant's action as a Class I recall. For more information on the FDA classifications, visit www.fda.gov.

What To Do

Patients who have been implanted with one of the devices listed above are urged to consult their physician to discuss the benefits and risks of removing the potentially defective devices.

If you've been implanted with a defective pacemaker or defibrillator, you may be eligible for compensation. Please call our attorneys at 1-866-218-3776 for a free consultation.

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