Medtronic Announces Voluntary Recall of Certain LIFEPAK 500 AEDs

Medtronic is voluntarily recalling a limited number of LIFEPAK 500 automated external defibrillators (AEDs).

The AED may continue to display a "connect electrodes" message and may not analyze the patient's heart rhythm even when the electrodes are properly connected. Failure to analyze the patient's heart rhythm will inhibit defibrillation, if it is needed. This action affects 1,924 first-generation LIFEPAK 500 AEDs that were manufactured in 1997, which represents approximately 1 percent of LIFEPAK 500 AEDs currently in use worldwide.

Medtronic has received 54 incident reports with this specific group of LIFEPAK 500 AEDs, including eight instances where it may have prevented patient resuscitation, which corresponds to less than 1 percent of patient uses. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product. The FDA has been apprised of this action and has classified this action a Class I recall.