On June 17, 2005, Guidant Corp. announced the first recall of Guidant defibrillator heart devices based on information that the devices had failed on at least 45 occasions. Guidant extended the recall on June 24, 2005 to cover additional defective defibrillators.
On July 28, 2005, the company warned doctors that a defect in some 28,000 pacemakers still in use by patients may necessitate replacement of the devices. Warnings on additional pacemakers were made on September 22, 2005, when Guidant Corp. announced that the Insignia and Nexus devices can experience a sudden loss of pacing.
The company presently faces about 145 individual lawsuits involving its defective defibrillator and pacemaker devices, and an additional 60 class action lawsuits. It is likely the company will face several thousand additional lawsuits over the next several years. In fact, Guidant already has been informed of more than 2,500 claims from individuals who may file lawsuits against the company.
Several government agencies have launched investigations into Guidant and the way it has handled reports of device malfunctions. In fact, in January 2006, the Justice Department requested from a Texas lawyer documents in his possession showing that the company continued selling devices to patients it knew were defective.
If you have been injured by a defective Guidant defibrillator or pacemaker and would like more information on filing a lawsuit to recover for your injuries, please contact us.
- Contak Renewal
- Contak Renewal 2
- Contak Renewal 3
- Contak Renewal 3 AVT
- Contak Renewal 3 CRT-D
- Contak Renewal 3 HE CRT-D
- Contak Renewal 4
- Contak Renewal 4 AVT
- Contak TR
- Discovery
- Discovery II
- Insignia
- Intelis II
- Meridian
- Nexus
- Pulsar
- Pulsar Max II
- Renewal 3 AVT
- Renewal 4 AVT
- Renewal RF
- Ventak Prizm 2 DR
- Ventak Prizm AVT
- Virtus Plus II
- Vitality 2 DR
- Vitality 2 VR
- Vitality AVT
- Vitality DS DR
- Vitality EL DR
On September 22, 2005, Guidant Corp. announced warnings for two additional pacemakers—the Insignia and the Nexus. These devices can fail, resulting in sudden and intermittent or permanent loss of pacing.
The FDA announced on July 1, 2005 that 20,600 Guidant defibrillators would be given the highest recall priority. According to the FDA, these devices have a "reasonable probability" of malfunctioning and could cause serious injuries or even death. The devices classified as highest priority include:
- Ventak Prizm 2 DR (model 1861)
- Contak Renewal (model H135)
- Contak Renewal 2 (model H155)
Guidant further announced on July 18, 2005 that some 28,000 pacemakers were defective and may need to be replaced. The company indicated it was aware of 69 failures among these pacemakers, all manufactured between 1997 and 2000. The problems involve a degraded sealing component that may allow excessive moisture into the devices. The company has recommended that doctors consider replacing the devices.
The FDA is considering whether to classify this warning as a recall of the affected pacemaker devices. Affected models include: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR.
The company has acknowledged that as a result of the various defects announced beginning in June 2005, many patients will be required to undergo invasive surgery to replace defective units. If you have questions about your health, we encourage you to contact your physician to discuss treatment options.
February 2002
Guidant was aware that its defibrillators were short-circuiting at the rate of about one per month.
April 16, 2002
The company made changes to the devices to attempt to correct the malfunction. In spite of the fact that
the company had substantially modified the device,
it continued selling the older, defective devices until May 23, 2005.
March 14, 2005
Joshua Oukrop, a 21-year-old college student, collapsed and died during a bicycle ride with his girlfriend.
His Guidant defibrillator short-circuited, leading to his death.
May 23, 2005
Guidant first admits publicly the flaw with their heart devices after learning the New York Times was preparing
to publish an article exposing problems with the Ventak Prizm 2 DR.
June 17, 2005
Guidant announced the first of several recalls.
Some Guidant defibrillators have defective wiring, causing the medical device to short circuit. Guidant Corp. has indicated that some patients will need to undergo invasive surgery to remove the defective device and install a new defibrillator.
Guidant first acknowledged problems with one of its devices in April 2005, when the company informed doctors that the Ventak Prizm 2 DR had failed numerous times due to the wiring defect. The company redesigned the device to correct for the problem, but inexplicably continued to sell the defective units. As of June 17, 2005, Guidant had received 28 reports of failures among patients implanted with this model.
The company had been criticized for its delay in alerting treating physicians to possible flaws in the device. Guidant had waited three years before telling doctors that 24,000 patients had been implanted with a device that could be rendered inoperable due to a an electrical problem. Guidant justified the delay because it argued that the malfunction rate was low and the risk therefore was not significant.
The FDA has announced the agency is investigating the circumstances surrounding Guidant's three year delay in reporting critical problems to treating physicians. The investigation may result in consent decrees, civil fines, or even criminal inquiries.
Boston Scientific Filing: 550 Lawsuits from Guidant Recalls 
Boston Business Journal
August 11, 2006
Boston Scientific Recalls More Guidant Heart Devices
The Boston Globe
June 26, 2006
Boston Scientific Warns of Flaw in Heart Aids
The Boston Globe
May 16, 2006
Inquiry Arranged by Guidant May Aid Lawsuits and Critics
The New York Times
March 22, 2006
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If you or a loved one has been injured by a defective Guidant heart device, you may be entitled to compensation. You should immediately contact lawyers experienced in matters involving dangerous medical devices.
For more information about the Guidant recall and information on filing a Guidant lawsuit, please complete our online contact form.
Martin & Jones represents more than 30 people harmed by defective Guidant heart devices. We invite you to contact us for a free, confidential consultation about your legal rights.
We have a reputation for taking on tough, serious cases and have successfully represented individuals in claims against 30 of the 100 largest corporations in America.
We will represent Guidant defibrillator and pacemaker patients throughout the United States. We can help you, too, wherever you live.