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Guidant Pacemaker Recall

On July 18, 2005, the following are models of Guidant pacemakers, manufactured between November 25, 1997 and October 26, 2000, of which some 28,000 remain implanted in patients worldwide.

- 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

Pacemakers of this type are surgically implanted in persons with a heart disease affecting the heart's ability to generate and conduct electrical impulses. These devices generate small electrical impulses that trigger the heartbeat.

The reason why they are recalled is because a seal within the devices can 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.

On September 22, 2005, Guidant issued a recall for some of its Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization. Guidant said that 36 out of 49,500 devices experienced loss of pacing output, while 16 out of 341,000 devices suffered a telemetry failure.

The recall expanded in June 2006 when Boston Scientific, which bought Guidant in 2006, announced in the recall of more defibrillators and pacemakers. The recalled devices include Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers. On June 23, 2006 Guidant issued a warning letter to physicians, informing them of the recall expansion and urging patient exams and possible removal of the defective devices.

If you or someone you love has been injured by A Guidant Pacemaker, defibrillator or an ICD (implantable cardioverter-defibrillator), please contact us immediately so we can get you in touch with legal professionals who are experienced with the Guidant Pacemaker Recall.

 
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