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Guidant Pacemakers
& Related Newswire
6/27/2006 9:31:00 AM | Boston Scientific to recall defective heart devices
=(0) Boston Scientific has issued another recall for its Guidant division, on a variety of cardiac devices: some Insignia, Nexus and Contak Renewal pacemakers; and Ventak Prizm 2, Vitality, and Vitality 2 implantable defibrillators. A defect was found that could lead to premature battery failure. Five malfunctions, but no deaths, have been re...
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6/8/2006 5:03:00 PM | Guidant never sent doctors letter about defibrillator risks
=(0) Guidant considered warning doctors about a malfunction in its implantable defibrillator devices - but decided not to, according to documents. Instead of a warning letter that had been drafted, Guidant sent a routine "product update". Ultimately, Guidant ended up recalling the devices in question, and some pacemakers as well, after at least sev...
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5/31/2006 11:11:00 AM | UA doctor barred from research on humans
=(0) The FDA has barred a University of Arizona cardiologist from conducting research using human subjects. Dr. Paul Fenster was found to have violated rules protecting patient safety after his own University reported him to the FDA. The research involved implanted Guidant heart pacemakers. Breaches of rules included using doctors and pat...
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4/28/2006 12:33:00 AM | BSX listens to Heart Rhythm Society
=(0) Boston Scientific Corp. says it intends to implement all the recommendations put forth by the Heart Rhythm Society. These guidelines were developed following a recall of implanted cardiac defibrillators last year, and include: using remote monitoring to keep track of devices; independent committees for assessing device performance; direct...
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4/26/2006 5:06:00 PM | Heart Device Risks Examined
=(0) A doctor's group, the Heart Rhythm Society, has called for better oversight of their products and better communication between medical device makers, doctors, and government with regard to defective devices and recalls. Several recalls occurred last year, some invoving Guidant, now owned by Boston Scientific. However another study found that peopl...
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4/26/2006 12:03:00 AM | Implantable Defibrillators Can Be Erratic, Studies Find
=(0) Three studies, recently published in the Journal of the American Medical Association, examine the reliability statistics for implantable cardiac defibrillators. These devices are meant to detect an irregular heartbeat and deliver an electric shock to restore normal rhythm. Compared to pacemakers, which speed up the heartbeat with lower p...
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3/14/2006 9:08:00 AM | Deaths no higher with recalled heart devices: study
=(0) A study has revealed that patients implanted with recalled heart devices do not have higher fatality rates than those patients who use products equipped with no safety warnings. Prominent defibrillator and pacemaker manufacturer Guidant Corp., has been issued numerous recalls and safety warnings over the past few years for their devices. While som...
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3/13/2006 2:31:00 PM | Guidant: Now It’s Batteries
=(0) Notable defibrillator and pacemaker manufacturer Guidant Corp., which has already been subject to numerous recalls, may be facing another safety warning. Representatives for the corporation alerted users that the possibility of low battery voltage in some heart devices may be the cause of yet another recall. The manufacturer, based in Indianapolis,...
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