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Guidant Investigation

The law firm of Breit, Drescher & Imprevento, P.C. is pursuing litigation against Guidant Corp. related to the implantation, removal and replacement of these devices.

Defective Defibrillators

On June 17, 2005, Guidant Corp. recalled nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of defects that could lead to serious injury and death. Guidant extended the recall on June 24, 2005 to cover additional defective devices. Guidant Corp. failed to inform doctors or patients for three years that some of these defibrillators had a defect that caused the devices to short-circuit. The defective Guidant models include:

• Contak Renewal AVT
• Contak Renewal 3
• Contak Renewal 4
• Contak Renewal 3 AVT
• Contak Renewal 4 AVT
• Contak Renewal RF
• Contak Renewal Model H135
• Contak Renewal 2 Model H155
• Ventak Prizm 2 DR Model 1861
• Ventak Prizm AVT
• Vitality AVT

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.

As of June 2005, Guidant was aware of 43 reports of device failures, and two patient deaths. Guidant has acknowledged that the actual rate of failure may be higher than the reported rate and that the number of associated deaths may be underreported, since implantable cardio-defibrillators are not routinely evaluated after death. The FDA and Guidant have advised physicians and patients to make individual decisions about whether to remove and replace the affected defibrillators on the basis of the specific medical situation of the patient.

The FDA announced that 20,600 of the affected devices would be classified under the highest recall priority designated by the agency, a Class I recall. The FDA defines a Class I recall as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Defective Pacemakers

Guidant has also issued an advisory warning physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide.

The following Guidant Corporation pacemakers are the subject of the advisory warning:

• Pulsar Max
• Pulsar
• Discovery
• Meridian
• Pulsar Max II
• Discovery II
• Virtus Plus II
• Intelis II
• Contak TR

If you or your loved ones have suffered injuries or have legal concerns related to these products, please contact us at (866) 669-0848. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.

Legal Disclaimer: The above information is not intended to be or to replace legal advice from Breit, Drescher & Imprevento, P.C. Consult a Breit, Drescher & Imprevento lawyer for individual advice regarding your own possible Guidant litigation. Confer with your doctor or other qualified medical professional before removing any device and before changing your own personal healthcare regimen.

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