Updated 2007- Boston Scientific, the company which bought out GuidantCorporation, has assumed the reponsibility of Guidant's liabilities - over a hundred individual and class action lawsuits resultant from the company's pacemaker products.  

Guidant Corporation has recalled certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators.  The FDA has issued a notification to doctors and healthcare providers. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification are:
  • PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
  • CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
  • CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices' inability to deliver an electrical shock during episodes of arrhythmia -- which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction. FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision. FDA advises patients to take the following steps:
  • If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
  • Continue to keep your regular doctor appointments.
  • If you feel an electrical shock from your device, immediately contact your doctor.
  • If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.
Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information. See your doctor if you have received a Guidant defibrillator device and you are concerned about your safety. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit. Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.

See Also

  1. Medical Devices & Implants
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