The FDA has classified this as a class II recall, which means that the malfunctioning device may cause “temporary or medically reversible adverse health consequences” with a remote probability of serious consequences. Of the 67,000 devices affected by this notice, there have been only 6 confirmed failures, none of which resulted in death or injury.

Fortunately, the risk can be reduced even more by reprogramming your device. We are recommending that you continue to have your device checked regularly in the office. Your ICD will be automatically reprogrammed at your next visit. As usual, if you should hear beeping from your ICD, please call our office immediately.