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Guidant & Related Newswire
6/27/2006 9:31:00 AM | Boston Scientific to recall defective heart devices
Comments:(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
Comments:(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 seven patient deaths. The failure to warn, and continued marketing of the defective devices up until the recall, are now the subject of lawsuits and a government investigation.
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6/2/2006 11:53:00 AM | 20 insurers sue over defective defibrillators
Comments:(0) Guidant faces a lawsuit over defective defibrillators - however this one is not from patients, but from twenty Blue Cross and Blue Shield Plans, which must bear the consequences of increased health costs for those harmed. Patients whose internal defibrillators have been recalled face a sobering dilemma: have the device replaced, or leave it in. Replacing the defibrillator actually carried a higher risk because of surgical complications, but either way, the patient faces increased medical monitoring and health care costs. The plaintiffs in this lawsuit say Guidant knew about the defect for three years before it issued a recall and in that time, many devices were implanted that should not have been.
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5/31/2006 11:11:00 AM | UA doctor barred from research on humans
Comments:(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 patients who were not approved or eligible, respectively, for the study; not keeping accurate records; and not reporting deaths or other "adverse effects" to the FDA as required. Dr. Fenster maintains his research is valid and the errors were "clerical".
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5/16/2006 4:30:00 AM | New Guidant warning issued
Comments:(0) Boston Scientific has advised doctors that it discovered a flaw in certain defibrillator models made in March 2005. The models in question are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3, 4, and 4 AVT. The problem lies in a defective capacitor and doctors are urged to check their patients who have this device implanted.
This is the latest in a string of recalls for Guidant defibrillators, but this flaw was discovered by Guidant's new owner, Boston Scientific, after it bought the company last month.
Over 300 lawsuits have so far been filed with regard to defective defibrillators from previous recalls.
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