Parker, Waichman, Alonso LLP

2005 Recall
Guidant Corp. informed doctors about a new round of safety problems with its implantable heart devices. Guidant, recently recalled many of its heart devices because of safety concerns, said as of July 11, 2005; it had identified 69 of its older pacemakers that may have failed. Approximately 78,000 of the devices were distributed, and close to 28,000 remain implanted in patients. Guidant said the devices have not been sold or implanted for the past four years.

The problem involves a hermetic sealing component that may degrade over time, resulting in higher-than-normal moisture within the pacemaker that could cause "serious health complications. The U.S. Food and Drug Administration may classify this action a recall, Guidant said. Although no failures have been reported prior to 44 months of service, the likelihood increases with time. Guidant's modeling predicts the rate of failure in the remaining implanted devices to be between 0.17% and 0.51% over the rest of the device's life.

The pacemaker brand names involved are Pulsar, Pulsar Max, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, and Contak TR. Guidant recommended that physicians consider replacing the devices for pacemaker-dependent patients, and it advised patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate. Guidant has confirmed 20 reports of loss of pacing output, including five patients experiencing syncope (temporary loss of consciousness and posture).

Loss of pacing output has also been associated with reports of presyncope (lightheadedness), requiring hospitalization. Additionally, Guidant has two reports of sustained maximum sensor rate pacing in which heart failure may have developed. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died.

2006 Recall
On June 26, 2005, Guidant in conjunction with the FDA notified patients and medical professional that the INSIGNIA and NEXUS implantable pacemakers and the Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers have been linked to five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Individuals with these pacemakers may suffer irregular or permanent loss of output, telemetry, and or premature battery depletion.

If you or a loved one suffered injuries from a Guidant Pacemaker, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.