Guidant Class I Recall

Prizm 2 DR (model number 1861) manufactured before April 16, 2002, the Contak Renewal (model number H135) and the Contak Renewal 2 (model number H155). manufactured before August 26, 2004



These devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart. This may prevent the treatment of an abnormal heart rhythm and it may cause the device to fail.

There is no way to determine if a particular device will malfunction in the future.

Fortunately, the risk of a failure is extremely low. Out of 42,000 devices worldwide, there have been only 43 failures (0.01% risk, or approximately one in 10,000). There have been 2 deaths reported due to this malfunction.

Although the FDA has classified this as a class I recall, this does not necessarily requie the removal of the defibrillator. In fact, we are recommending that you continue to have your device checked regularly in the office. If you do experience a shock from your ICD, you should call our office immediately or proceed to the closest Emergency Department in order to have your device checked. Finally, as usual, if you should hear beeping from your ICD, please call our office immediately