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GUIDANT DEFIBRILLATORS EVALUATION

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Guidant Corp. has recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly. The Guidant defibrillator defects include short circuiting, problems with the magnetic switch and computer memory problems. The defect that causes short circuiting of the device has caused two deaths to date, including the sudden death in March 2005 of a 21-year-old college student. Following are details of the models affected by the recall and the follow-up advisory:

June 16, 2005 - Guidant recalled 50,000 defibrillator devices including the following models:

· Prizm 2 DR, Model 1861, manufactured on or before April 16, 2002

· Contak Renewal, Model H135, manufactured on or before Aug. 26, 2004

· Contak Renewal 2, Model H155, manufactured on or before Aug. 26, 2004

· Prizm AVT Vitality AVT Renewal 3

· AVT Renewal 4 AVT

June 24, 2005 - Guidant issued an advisory about additional defibrillator devices including the following models:

· Contak Renewal 3 and 4

· Renewal 3 and 4 AVT

· Renewal RF

Guidant claims that it discovered the short circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety.

Heart patients with a defibrillator who are unsure if their device is one of the malfunctioning models should contact their doctor as soon as possible to determine if their model requires replacement, if their device can be reprogrammed, or if their device is not affected by the recently announced safety issues.

Guidant Defibrillators

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Which Guidant Cardiac Debfibrillator was Implanted?
Ventak Prizm AVT
Prizm 2 DR
Contak Renewal
Contak Renewal 2
Vitality AVT
Renewal 3 AVT
Renewal 4 AVT ICD
Other Debfibrillator
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