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On July 18, 2005, Guidant, a large manufacturer and distributor of implantable cardioverter defibrillators (ICD) and devices for cardiac resynchronization therapy (CRT), a type of pacemaker, announced a voluntary recall on several of their products. Soon after, the FDA reclassified the voluntary recall as a Class I recall, which means that there is a reasonable probability that the malfunctioning device will cause serious adverse health consequences or death.

The devices are designed to be implanted in the chest area and monitor heart function, much like a pacemaker. If an irregularity is detected, then an electrical impulse (shock) or a series of impulses are delivered to various parts of the heart to restart normal function.

The malfunction occurs when a seal with the device leaks, allowing moisture to affect the unit’s electronic circuits. Moisture within the circuits can cause a rapid heart rate or cause the unit to fail all together. The failure can occur without warning and can lead to possible heart failure, loss of consciousness and death.

To date, twenty failures due to the leakage have been confirmed resulting in two deaths and five people losing consciousness, though as many as 69 may have failed.

The following Guidant defibrillator and pacemaker products, manufactured between November 25, 1997 and October 26, 2000 were recalled:

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
Contrak TR® Model 1241
Virtus Plus® II* Models 1380, 1480
Intelis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

If you or a family member has one of the Guidant defibrillator and pacemaker products that has been recalled and has experienced shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate, seek medical attention immediately. If you or someone you know has experienced a problem with a Guidant defibrillator or pacemaker device, contact the lawyers of Hill Boren. We're currently investigating the Guidant recall and would like to help you and your family.