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| Guidant Devices |
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Information on the Warning from Guidant |
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Guidant Corp. initially warned physicians about problems with the Ventak Prizm 2 DR in May 2005. |
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| Problem | |
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Deterioration in a wire insulator can result in a short in the device, resulting in a failure of the device. |
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| Reports of Injuries | |
| As of December 14, 2005, Guidant Corp. announced they had received 28 reports of this failure worldwide, including two deaths. FDA records indicate that 14 of the known failures occurred in a relatively short period between January 2004 and March 2005. | |
| Models | |
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The problem affects Model 1861 units manufactured before April 16, 2002. |
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| Recommendation | |
| Patients should consult with their physicians to discuss possible removal of the device. Patients also should continue with ongoing monitoring to detect any problems with the device. | |
| Documents | |
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Questions and Answers
for Patients: Ventak Prizm 2 DR Model 1861 Urgent Medical Safety
Information & Corrective Action |
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O'Steen & Harrison, PLC presently is handling legal claims on behalf of those injured by defective Guidant heart devices. For free answers to your legal questions about the Guidant Ventak Prizm 2 DR (model 1861), just call us toll-free at 1-800-883-8888 or submit this online contact form. |
