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Medical equipment industry

FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators

Strategic Insights

— 2 min read

The Food and Drug Administration (FDA) has classified Guidant Corporation's implantable defibrillators, which have been recalled due to device malfunction, into three categories based on the probability of serious adverse health effects. The FDA has recommended that patients and doctors take appropriate action, if necessary, and has provided additional instructions for safe use of the devices.

Key Takeaways:

  • The FDA has classified Guidant's implantable defibrillators into three categories: Class I (most serious), Class II (temporary or medically reversible adverse health consequences), and Class III (no health risk).
  • The Class I recall involves 42,000 affected devices worldwide, with 20,600 still implanted, and two associated deaths.
  • The affected devices are PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2.
  • The Class I recall requires Guidant to disclose the device malfunction to patients and doctors while providing additional instructions for safe use of the devices.
  • Guidant has recommended that patients continue to keep their normal doctor appointments, contact their doctor as soon as possible if they feel a shock, and go immediately to their doctor or the emergency room if they hear "beeping" from their device.
  • The FDA has classified the previous actions taken by Guidant for VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT devices as a Class II recall.
  • The Class II recall involves 21,000 devices implanted worldwide, with two incidents confirmed, neither of which resulted in death or injury.
  • Guidant has recommended the device be reprogrammed during the patient's next doctor visit and is developing an additional non-invasive software solution for this problem.
  • The FDA has classified the previous actions taken by Guidant regarding CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF devices as a Class II recall.
  • The Class II recall involves 46,000 devices and has resulted in four confirmed occurrences of component failure, which may limit available therapy.

Statistics:

  • The FDA has classified 42,000 implantable defibrillators as Class I recalls worldwide, with 20,600 still implanted.
  • Two associated deaths have been reported to the FDA.
  • Approximately 46,000 devices are subject to a Class II recall.
  • Two incidents have been confirmed in the Class II recall, neither of which resulted in death or injury.
  • Four occurrences have been confirmed in the Class II recall involving component failure.
  • Guidant has developed an additional non-invasive software solution for the Class II recall, expected by the end of the year.

Sources:

  • M2 PressWIRE - "FDA updates consumers on Guidant Corporation's implantable defibrillators" (July 4, 2005)
  • FDA website - "Guidant Corporation Implantable Defibrillators" (no date)
  • Guidant website - "Physician Communications" (no date)

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