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Two deaths and dozens of product failures have led to the worldwide recall of tens of thousands of cardiac defibrillators implanted in patients susceptible to dangerous abnormal heart rhythms.
The devices, made by the Guidant Corp. of Indianapolis, are programmed to deliver a potentially lifesaving electrical shock when heart rhythms go awry. Several potential problems have been detected. Both deaths and most of the failures have been linked to the following:
* Ventak Prizm 2 DR, model 1861, made before April 17, 2002. They could short-circuit. In use: approximately 17,000. The toll: 28 failures including one death.
* Contak Renewal, model H135, and Contak Renewal 2, model H155, both made before Aug. 27, 2004. They, too, could short out. In use: approximately 11,900. The toll: 15 failures including one death.
Also recalled were 21,000 Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT models. Guidant has confirmed two failures, neither involving injury. With these, a memory problem could prevent detection and correction of ...