Defibrillator Recall
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In June of 2005 Guidant Corporation recalled cardiac defibrillators implanted in 50,000 patients around the world because of potentially fatal malfunctions. In the United States there are approximately 38,000 patients with Guidant brand defibrillators which have failed 45 times and are responsible for at least two deaths since May 30th.
The recalled models are listed below:
VENTAK PRIZM 2 DR The problem with the Ventak Prizm 2 DRs is that they might undergo a manufacturer defect of the wire insulator in the lead connection block. This defect can potentially cause a short circuit and prevent the device for providing help at the time needed. There has already been one death related to this malfunction.
CONTAK RENEWAL The Contak Renewal devices also have a fatal manufacturing defect. The wire insulation used on the lead connector block has been known to deteriorate causing a short ciructui in the titanium case of the device. There are about 15 failure so far, and one death so far.
VENETAK PRIZM AVT This device provides a trial therapy for those suffering from fatal heart problems. This device has a flaw in its memory system that can prevent the defibrillator from delivering the appropriate amount of therapy needed. This device has failed twice but there are no reported serious injuries or fatalities related to it. Still, patients are advised to report to their doctors to receive a necessary programming change.
VITALITY AVT The Vitality AVT was designed for thin people whom a smaller implant device would be less noticeable. Guidant thinks that there are about 21,000 of these units that might suffer from a memory error that will prevent the device from delivering the proper therapy.
RENEWAL 3 AVT This unit also has undergone an memory error that may prevent the device from recognizing a critical situation. There have been approximately two failures with this unit, but neither resulted in serious injury nor death.
RENEWAL 4 AVT Guidant has issued a recall of 21,000 units of the Renewal 4 AVT devices. This product has a potentially fatal manufacturing defect in the memory system program. This flaw can prevent the device from monitoring and correcting dangerous heart conditions. If you have one of these devices you should report to your doctor immediately for a programming readjustment to reverse the problem.
Product Information Bulletin. - Product Contamination and Tampering Incidents, including Extortion, Recalls, Animal Rights Incidents & Foodborne Illness Counts.
Please visit http://www.sddefenselawyers.com/guidant-defibrillator-recall/ for more information on the Guidant Defibrillator Recall. This article may be freely reprinted as long as this resource box is included and all links stay intact as hyperlinks.
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