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Medical equipment industry

FDA Announces Guidant Class I Pacemaker Recall

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) is notifying healthcare providers and patients about a voluntary recall of certain pacemakers manufactured by Guidant Corporation. These pacemakers have a seal that can leak, allowing moisture to damage the electronic circuits, potentially leading to device failure, loss of consciousness, heart failure, and even death. The affected models include PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN, PULSAR MAX II, DISCOVERY II, CONTAK TR, VIRTUS PLUS II, and INTELIS II models. Approximately 18,000 of these devices remain in service in the United States, while an additional 10,000 are in service in other countries.

Key Takeaways:

  • The FDA has classified Guidant's pacemaker recall as a Class I recall, indicating a reasonable probability of serious adverse health consequences or death.
  • The affected pacemakers were manufactured between November 25, 1997, and October 26, 2000.
  • Only the listed models are affected by this recall: PULSAR MAX, PULSAR, DISCOVERY, MERIDIAN, PULSAR MAX II, DISCOVERY II, CONTAK TR, VIRTUS PLUS II, and INTELIS II models.
  • Guidant estimates that the failure rate from the leakage defect will be between 0.17% and 0.51% over the remaining lifetime of the devices.
  • The FDA is not making a recommendation about whether a patient should have their pacemaker replaced, as this decision should be made by the patient in consultation with their physician.
  • Patients who believe they are pacemaker dependent should contact their physician soon to discuss treatment options.
  • Removal and replacement of the device may pose some risk, and patients and physicians should carefully discuss this matter before making a decision.
  • Guidant has posted information for physicians on its website, and the FDA has set up a MedWatch program for reporting adverse events.

Statistics:

  • Approximately 18,000 affected devices remain in service in the United States.
  • An additional 10,000 affected devices are in service in other countries.
  • Guidant has received reports that 69 pacemakers may have failed due to the leakage defect.
  • Twenty of the devices were confirmed to have stopped providing pacing output, resulting in loss of consciousness in five patients.
  • Guidant has posted information for physicians on its website.
  • The FDA has set up a MedWatch program for reporting adverse events.

Sources:

  • M2 PRESSWIRE - "FDA: FDA announces Guidants Class I Pacemaker Recall" (July 25, 2005)
  • FDA MedWatch program: http://www.fda.gov/medwatch/
  • Guidant Corporation: www.guidant.com

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