Medtronic Recalls Limited Number of LIFEPAK 500 Automated External Defibrillators

Strategic Insights -

Medtronic, Inc. is voluntarily recalling a limited number of first-generation LIFEPAK 500 automated external defibrillators (AEDs) due to a potential issue that may prevent the device from analyzing a patient's heart rhythm, even when the electrodes are properly connected. This action affects 1,924 AEDs manufactured in 1997, which is approximately 1% of LIFEPAK 500 AEDs currently in use worldwide. The recall is based on 54 incident reports, including eight instances where the issue may have prevented patient resuscitation, which corresponds to less than 1% of patient uses. Medtronic is working to update or upgrade affected AEDs at no charge and has notified customers via certified mail.

Key Takeaways:

  • The recall affects 1,924 first-generation LIFEPAK 500 AEDs manufactured in 1997, representing approximately 1% of LIFEPAK 500 AEDs currently in use worldwide.
  • The affected AEDs may not analyze a patient's heart rhythm even when the electrodes are properly connected, which can inhibit defibrillation if needed.
  • Medtronic received 54 incident reports, including eight instances where the issue may have prevented patient resuscitation, corresponding to less than 1% of patient uses.
  • A recently completed theoretical engineering analysis estimates that this issue may occur on up to 8% of patients.
  • Medtronic will update or upgrade customer devices at no charge and has distributed notices to customers via certified mail.
  • The affected AEDs may remain in service, and customers are being contacted with recommendations for use and replacement schedules.
  • Only certain monophasic LIFEPAK 500 AEDs manufactured in 1997 are included in this recall.
  • Medtronic, Inc., a medical technology company, is providing lifelong solutions for people with chronic disease.
  • The U.S. Food and Drug Administration (FDA) has classified this action as a Class I recall, indicating a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.

Statistics:

  • 1,924 LIFEPAK 500 AEDs manufactured in 1997 are affected by the recall, representing approximately 1% of LIFEPAK 500 AEDs currently in use worldwide.
  • 54 incident reports were received by Medtronic, including eight instances where the issue may have prevented patient resuscitation, corresponding to less than 1% of patient uses.
  • Up to 8% of patients may experience the issue, according to a theoretical engineering analysis.
  • The FDA has classified the recall as a Class I recall, indicating a reasonable probability of serious adverse health consequences or death.

Sources:

  • Health & Medicine Week editors, "Medtronic Recalls Limited Number of LIFEPAK 500 Automated External Defibrillators," 2005.
  • NewsRx.com, "Medtronic Recalls Limited Number of LIFEPAK 500 Automated External Defibrillators," 2005.