Medical Device:

Guidant Defibrillators

Guidant Cardiac Defibrillators

Manufacturer: Guidant (now owned by Boston Scientific)

A defibrillator is a small medical device implanted in the body and used to ensure patients maintain a regular heartbeat. Arrhythmia (irregular heartbeat) is recognized by the device and small electrical shocks are administered to the heart to return it to its proper rhythm. Errors in wiring cause the Guidant defibrillators to short circuit. These malfunctions have very serious consequences.

Following the FDA’s notification in June of 2005, approximately 50,000 devices are being recalled. About 21,000 can be reprogrammed externally; the rest need to be replaced.

The devices recalled are:

  • Pulsar Max II
  • Discovery
  • Discovery II
  • Virtus Plus II
  • Intelis II
  • Contak TR
  • Ventak Prizm 2 DR
  • Contak Renewal 1 and 2
  • Ventak Prizm AVT
  • Vitality AVT
  • Renewal 3 and 4 AVT
  • Contak Renewal 3 and 4
  • Renewal RF

Patients believing they have one of these products should contact a medical professional immediately to determine if they are, in fact, effected by the recall, and to discuss the appropriate means of proceeding.