New Warning About Defect In Guidant Heart Devices

Jamie Sheller

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Boston Scientific recently announced a new defect in Guidant heart defibrillators that may cause the devices to quit prematurely. The battery failure is due to a defective low-voltage capacitor. According to the company, the problem affects the following models: Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and Contak Renewal 4 AVT. The capacitor in question came from a single supplier. Last year, the FDA halted the export and pre-market approval of some Guidant devices until the company corrects problems in production and quality process in its Minnesota production plant. Those problems have not all been fixed, and the ban remains in place. See more information on the recent Guidant defect announcement.