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Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II, Virtus Plus II, Intelis II, Contak TR
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guidant pulsar recall Information on the Warning from Guidant

Guidant Corp. initially warned physicians about problems with these devices on July 18, 2005.
Problem

Degradation in a sealing component can result in a higher than normal moisture content within the pacemaker case. The problem can lead to one or more of the following:

  1. Premature battery depletion resulting in loss of telemetry and/or loss of pacing output without warning
  2. Inappropriate accelerometer function (if programmed ON), resulting in:
    - sustained pacing at the programmed maximum sensor rate (MSR)
    - lack of appropriate accelerometer rate response during activity
  3. Appearance of a reset warning message upon interrogation
  4. Inappropriate early display of replacement indicators
Reports of Injuries or Failures
As of July 11, 2005, Guidant Corp. announced they had received 69 reports of devices exhibiting this failure mode. The company has confirmed the failure in 52 of those devices and is testing the failure in 13 other devices.
Models
This problem affects all models manufactured between November 25, 1997 and October 26, 2000.
Recommendation
Patients should consult with their physicians to discuss possible removal of the device. Patients also should continue with ongoing monitoring to detect any problems with the device.
Documents

Questions and Answers for Patients
Guidant Corp.
July 22, 2005

Letter to Patients
Guidant Corp.
July 22, 2005

Letter to Physicians
Guidant Corp.
July 18, 2005

Our Lawyers Can Help You

guidant lawyers

O'Steen & Harrison, PLC presently is handling legal claims on behalf of those injured by defective Guidant heart devices.

For free answers to your legal questions about this Guidant warning, just call us toll-free at 1-800-883-8888 or submit this online contact form.