Guidant Updates Corrective Actions Regarding Its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT Implantable Cardiac Defibrillators

Guidant Corporation (NYSE:GDT) said today it is updating previous safety information regarding its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT devices. FDA may consider this action a recall. This update revises the original recommendations set forth in Guidant's June 17, 2005 letter...

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Bibliographic Details
Published inBusiness Wire p. 1
Format Newsletter
LanguageEnglish
Published New York Business Wire 22.07.2005
Subjects
Regulatory approval
INDIANAPOLIS
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Summary:Guidant Corporation (NYSE:GDT) said today it is updating previous safety information regarding its VENTAK PRIZM AVT, VITALITY AVT, and CONTAK RENEWAL AVT devices. FDA may consider this action a recall. This update revises the original recommendations set forth in Guidant's June 17, 2005 letter to physicians because new information indicates that one of the original recommendations can significantly increase the risk to patients. Physicians should use this information to decide how best to treat their patients. As described in the June 17, 2005 letter, Guidant has determined that the atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to latching where the device can lock up and thus affect available therapy. At that time, two occurrences had been confirmed out of approximately 20,950 devices implanted to date. As a result, one of Guidant's recommendations was to make a programming change to the device.