Recent Articles
05/31/05 - Doctors Seek Device-Flaw Database
Guidant's belated revelation of defect in its Prizm 2 defibrillator spurs call for changes
Indianapolis Star - Jeff Swiatek
Guidant Corp.'s startling public admission last week that it kept quiet for three years about a potentially deadly flaw in one of its widely sold defibrillators has left some heart physicians saying they shouldn't have to rely on manufacturers to report product defects.
05/26/05 - FDA INVESTIGATION OF GUIDANT CORP. PROCEEDING
www.Newsinferno.com -
Guidant has confirmed that it is “working with the FDA” regarding the agency's investigation of Guidant's belated admission concerning its knowledge of a flaw which could cause its internal heart defibrillator to short-circuit. On May 24, Guidant disclosed for the first time that it had waited three years before disclosing that it was aware of an electrical problem that had caused some 26 defibrillators to malfunction. The revelation came when Guidant learned that The New York Times was about to publish a story on the defibrillator.
05/25/05 - DELAY IN DISCLOSING FLAW IN DEFIBRILLATOR LEADS TO FDA INVESTIGATION OF GUIDANT CORP
www.Newsinferno.com -
Guidant Corp., the Indianapolis-based medical device manufacturer, has always maintained that its internal heart defibrillator, the Ventak Prizm 2 Model 1861, is safe and extremely reliable. (A defibrillator is a device designed to shock the heart back into a normal rhythm when it begins beating irregularly).
05/25/05 - FDA Begins Inquiry on Guidant Defibrillator Flaw
Agency says it wants to know everything about the problem with device
Indianapolis Star - Jeff Swiatek
The Food and Drug Administration began questioning Guidant Corp. on Tuesday about its delayed disclosure of a design flaw uncovered three years ago in one of its best-selling implantable heart defibrillators.
05/25/05 - Defibrillator-Maker Kept Silent About Defect
AP - Charles Wilson
The maker of an internal heart defibrillator is acknowledging it waited three years before telling some 24,000 patients and their doctors about an electrical problem that caused a small fraction of the devices to short-circuit.
05/25/05 - Guidant Confirms It's Working Qith FDA on Defibrillator Problem
AP - RICK CALLAHAN
Medical device maker Guidant Corp. confirmed Wednesday that it is cooperating with the Food and Drug Administration as the agency looks into why Guidant waited three years before disclosing a problem with one of its heart defibrillators.
05/24/05 - Guidant Delayed Disclosing Device Defect
Reuters -
Guidant Corp. failed to inform doctors or patients for three years that one of its defibrillators implanted in an estimated 24,000 patients had a defect that caused some of the devices to short-circuit and malfunction, the New York Times reported.
