Guidant Heart Devices
Pharmaceutical | Ongoing
Published May 17, 2007 10:04 AM
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What is a Guidant heart device?

Mechanical implantable heart device such as pacemaker or defibrillators known to significantly improve survival and the quality of life of patients.

What are the dangers associated with Guidant heart devices?

On June 17, 2005, Guidant Corporation recalled nearly 50,000 of its ICD's because of defects that could lead to serious injury and/or death. These models affected are: Contak Renewal, Contak Renewal 2, Ventak Prizm 2DR, Ventak Prizm AVT, and Vitality AVT. Less than one week later, Guidant issued a second safety advisory affecting the additional ICD's: Contak Renewal 3 & 4, Renewal RF, and Renewal 3 & 4 AVT.

Thereafter, on July 22, 2005, the FDA announced Guidant's Class I Pacemaker voluntary recall consisting of a seal within the device that can leak, allowing moisture to affect the electronic circuits. This defect can cause the failure to provide pacing or can cause heart failure and death.This recall affects the following pacemaker models manufactured between November 25, 1997 and October 26, 2000: Pulsar Models 0470, 0870, 0970, 0972, 1172, 1272, Pulsar Max Models 1170, 1171, 1270, Pulsar Max II Models 1180, 1181, 1280, Discovery Models 1174, 1175, 1273, 1274, 1275, Discovery II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286, Meridian Models 0476, 0976, 1176, 1276, Contak TR Model 1241, Virtus Plus II* Models 1380 & 1480, and Intelis II* Models 1483, 1484, 1485, 1384, 1385, 1349, 1499.

On, September 22, 2005, Guidant Corporation sent letters to physicians containing safety information regarding the Guidant models INSIGNIA** and NEXUS** implantable heart pacemakers. One or more of the following device behaviors may be observed: (1) Intermittent or permanent loss of pacing output without warning; (2) Intermittent or permanent loss of telemetry; and (3) Reversion to VVI mode or appearance of a reset warning message upon interrogation.

What can I do if I have been injured by a Guidant heart device?

If you or a loved one are the recipient of an implanted Guidant defibrillator or pacemaker and have suffered a serious side effect as the result of using this device, you may be entitled to compensation. For a free legal consultation, contact us today!

 

 

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