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Medtronic Announces Voluntary Recall of Certain Monophasic LIFEPAK 500 Automated External Defibrillators

Feb 25, 2005 | BUSINESS WIRE

Medtronic, Inc. today announced that it is voluntarily recalling a limited number of LIFEPAK(R) 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. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product.

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. In addition, a recently completed theoretical engineering analysis estimates that this issue may occur on up to 8 percent of patients.

Medtronic distributed notices via certified mail on Feb. 3, 2005, to customers who purchased AEDs in this group of devices. The company will update or upgrade customer devices at no charge by March 31, 2005. The affected AEDs may remain in service, and customers are currently being contacted with recommendations for use and replacement schedules. Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this action.

Medtronic is voluntarily recalling the affected AEDs. The U.S. Food and Drug Administration (FDA) has been apprised of this action. FDA classified this action as a Class I recall. The FDA defines Class I as a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

The LIFEPAK 500 is used by first responders such as firefighters, police and others trained in CPR/AED use and are first to arrive at the scene of a cardiac incident but do not have significant medical training.

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