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U.S. Department of Health and Human Services

Safety

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Medtronic LIFEPAK 500 Automated External Defibrillators

Audience: Emergency healthcare professionals and Cardiologists

[03/02/2005] Medtronic, Inc. and FDA advised healthcare professionals of a Class 1 recall of the 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. This action does not affect any other LIFEPAK 500 AEDs currently produced, or any other LIFEPAK product. 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.

UPDATE April 25, 2005 - An additional 396 monophasic LIFEPAK 500 AEDs were included in a voluntary recall originally announced on February 25, 2005. See link below.

[April 22, 2005 - Press Release - Medtronic, Inc.]
[February 25, 2005 - Press Release - Medtronic, Inc.]
[March 1, 2005 - Recall Notice - FDA]