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