March 25, 2005

At the link below you can find the U.S. Food and Drug Administration's (FDA) notification to health care providers and patients regarding the Guidant Corporation's voluntary recall of certain pacemakers. The FDA has classified Guidant's action as a Class I recall.

According to the FDA notification, “the FDA is not making a recommendation about whether a patient who has one of the Guidant pacemakers affected by this recall should have it replaced. This is a decision that should be made by the patient in consultation with his or her physician, based on the patient's history and medical condition. 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.”

Guidant has also posted additional safety information regarding certain ICDs and prior recommendations for treatment. To view this information click here.

The Heart Rhythm Society is providing this information to all members. The Heart Rhythm Society, working with the U.S. Food and Drug Administration (FDA), will be holding a conference September 16, 2005, in Washington, DC, to discuss suggested improvements regarding how physicians and patients are informed about the recalls of pacemakers and implantable cardioverter defibrillators (ICDs). The “Policy Conference on Pacemaker and ICD Performance” will provide a forum for physicians and other healthcare providers, government agencies, the medical device industry, and the public to discuss the current recall policy and explore achievable alternatives. More information regarding the Policy Conference will be available later this week via email and the Heart Rhythm Society website.