Medical Devices: Guidant

Guidant, which since has been purchased by Boston Scientific, recalled several models of its implantable defibrillators and pacemakers in 2005.  The FDA termed the Guidant action a Class I recall, indicating a reasonable probability that a malfunctioning Guidant defibrillator or pacemaker could cause serious injury or death.

In a letter to consumers affected by the Guidant recall, the FDA said that the defective defibrillators did not show any outward signs of impending failure.  The FDA also said there was no test that would predict whether the Guidant devices might fail.  

On June 26, 2006, Boston Scientific announced the recall of an additional 23,000 Guidant pacemakers and defibrillators, and asked doctors to check on those already implanted in 27,000 patients.  Read more about the most recent recall here.

The FDA has received reports of deaths that have occurred as a result of the failure of Guidant defibrillators and pacemakers.

If you or a family member has a Guidant implantable defibrillator or pacemaker, please contact your doctor immediately.

If you would like to speak with us about your legal rights, please call us at 1-800-961-HART.