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Guidant Corporation and Medtronic, Inc.
Medical Device Recalls

The United States Food and Drug Administration (FDA) has issued Class I Recalls, its highest priority recall, against many implantable cardiac defibrillators (ICD), cardiac resynchronization therapy defibrillators (CRT-Ds) and pacemakers manufactured and sold by Guidant Corporation and Medtronic, Inc. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The recalls affect the following Guidant Corporation devices:

Guidant Corporation pacemakers, manufactured between November 25, 1997 and October 26, 2000:

  • PULSAR® MAX Models 1170, 1171, 1270
  • PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
  • DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
  • MERIDIAN® Models 0476, 0976, 1176, 1276
  • PULSAR MAX II Models 1180, 1181, 1280
  • DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
  • CONTAK TR® Model 1241
  • VIRTUS PLUS® II* Models 1380, 1480
  • INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

Guidant Corporation CRT-Ds, manufactured on or before August 26, 2004:

  • CONTAK RENEWAL Model H135
  • CONTAK RENEWAL 2 Model H155

These Guidant Corporation devices have a manufacturing defect that can cause a seal within the devices to leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.

The recalls also affect the following Medtronic ICDs and CRT-Ds manufactured between April 2001 and December 2003:

  • Marquis™ VR/DR
  • Maximo™ VR/DR
  • InSync I/II/III Marquis™
  • InSync III Protect™

These Medtronic, Inc. devices have a design or manufacturing defect that have the potential to cause the device to experience rapid battery depletion due to a battery shorting mechanism. If shorting occurs, battery depletion can take place within a few hours to a few days, after which the device stops working, thereby leaving the patient without the life saving features for which the device was implanted.

If you believe that you or a loved one have a defective Guidant Corporation or Medtronic, Inc. implant, please contact us to discuss your legal rights.

More information:

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