• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Guidant Corporation Cardiac Pacemakers

Audience: Cardiologists/cardiovascular healthcare professionals

[UPDATE 07/25/2005] The FDA has classified Guidant's action as a Class I recall because of a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

[Posted 07/19/2005] Guidant notified physicians and patients of new safety information for certain models of cardiac pacemakers manufactured between November 25, 1997 and October 26, 2000. A hermetic sealing component used in these devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing. Physicians should consider the unique needs of individual patients and the specific technical recommendations set forth in the July 18, 2005 physician communication. Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

[July 27, 2005 - Recall Notice - FDA]
[July 22, 2005 - Press Release - FDA]
[July 18, 2005 - Press Release - Guidant]
[July 18, 2005 - Physician Communication - Guidant]