guidant pacemaker recall
Warning Information on Guidant Pacemakers Defective Guidant Devices
Issues

A defect in a sealing component can allow one or more of the following to occur:

  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 programmer maximum sensor rate
    - lack of appropriate accelerometer rate response during activity
  3. Appearance of a reset warning message upon interrogation
  4. Inappropriate early display of replacement indicators
Injuries and Failures
Guidant Corp. reported on July 11, 2005 that it had received 52 confirmed reports of failures worldwide. An additional 13 reports of failures were being investigated.
Affected Models

This warning affects all of the models named above manufactured between November 25, 1997 and October 26, 2000.

DEVICE MODEL NUMBERS
Pulsar Max 1170, 1171, 1270
Pulsar 0470, 0870, 0970, 0972, 1172, 1272
Discovery 1174, 1175, 1273, 1274, 1275
Meridian 0476, 0976, 1176, 1276
Pulsar Max II 1180, 1181, 1280
Discovery II 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
Contak TR 1241
Virtus Plus II 1380, 1480
Intelis II 1483, 1484, 1485, 1385, 1349, 1499
Recommendation
Patients with this device should contact their physicians to discuss possible removal of the device.
Guidant Communications

Letter to Patients
Letter to Physicians
Questions and Answers for Patients