Guidant Recalls Hit Pacemaker Line

After recalling more than 100,000 of its implantable cardiac defibrillator (ICD) devices in June, Guidant Corp. (Indianapolis) has now issued a voluntary recall of approximately 28,000 pacemakers. In mid-July, the company notified physicians, patients, and FDA that there was a potential safety flaw in some of its pacemaker models manufactured between November 25, 1997, and October 26, 2000. The flaw was attributed to the hermetic sealing component used in the devices, which could result in higher than normal moisture content and potentially cause an abnormal pacing condition.

The pacemaker devices covered by the recall include the following nine models: Contak TR, Discovery, Discovery II, Intelis II, Meridian, Pulsar, Pulsar Max, Pulsar Max II, and Virtus Plus II. Guidant reported that these models represent “an earlier generation design” and are no longer manufactured.

FDA classified Guidant's action as a Class I recall, the most serious type, and indicative of a “reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.”

Guidant has identified 69 adverse incidents, including one death, in which the device malfunction was likely caused by deterioration of the sealing component. Of the 78,000 units distributed, 28,000 remain implanted worldwide, with 18,000 still in use in the United States. The average implant age of the remaining U.S. units is 69 months. There have been no failures reported prior to 44 months of service.

Device malfunction has typically resulted in loss of pacing output, causing fainting, or sustained maximum output, resulting in rapid arrhythmia and potential heart failure. Other adverse device behaviors are also possible and can occur without warning. Based on incident reports and statistical models, Guidant estimates that the rate of failure in the remaining active implanted devices is between 1.7 and 5.1 per thousand over the remaining lifetime of the devices.

Guidant recommends that physicians consider replacing the recalled devices for “pacemaker-dependent” patients. The company also advises patients to seek “immediate medical attention” if they experience shortness of breath, dizziness, lightheadedness, or a prolonged fast heart rate.

FDA has posted the recall notice on its Web site and, while not making a specific recommendation on whether or not patients should have a recalled device replaced, generally endorses the advisory that Guidant has issued to physicians and patients. Daniel J. Schultz, MD, director of FDA's Center for Devices and Radiological Health, described pacemakers as “complex medical devices that can extend and improve the lives of many people who have heart rate abnormalities. However, they are not perfect and can malfunction.”

Pacemakers are generally thought to have a 7–10 year life. Many of the models being recalled are nearing or have exceeded their estimated product life and are beyond warranty coverage. However, Guidant is offering to provide a replacement device at no charge for physician-designated candidates. The company will also reimburse patients up to $2500 for medical expenses remaining after Medicare or other health-insurance coverage.