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Guidant
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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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6/2/2006 11:53:00 AM | 20 insurers sue over defective defibrillators =(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...
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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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5/16/2006 4:30:00 AM | New Guidant warning issued =(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...
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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 3:07:00 AM | Replacing heart device has high risk =(0) If your surgically implanted heart defibrillator is recalled, such as occurred recently with Boston Scientific devices - what do you do? Statistically, it is safer to not have it replaced, according to a new study, because risks of complications from the replacement surgery far outweigh risks of defibrillator failure. The study showed an ...
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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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4/21/2006 8:20:00 AM | Abbott Completes Acquisition of Guidant Vascular Business =(0) As part of the terms of Boston Scientific's acquisition of Guidant, Abbott has acquired Guidant's vascular device business unit. One of the devices that both Abbott and Guidant have developed is the stent, a piece of wire mesh that is inserted into an artery in order to keep it open and filter out blood clots. Newer stent versions contain...
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4/10/2006 8:15:00 PM | Guidant Trial on Recalled Heart Devices Will Be Postponed =(0) First the recall, now the lawsuits: the first lawsuit against Guidant to go to trial will begin in July, according to the Texas judge presiding over the case. The charges are fraud and deceptive trade pracices. Plaintiffs contend that Guidant knew that its defibrillators, implanted in the plaintiffs' chests, might be defective, but did not war...
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4/3/2006 4:09:00 PM | Guidant trial delayed over jurisdiction =(0) The first Guidant defibrillator trial is on hold because of jurisdictional questions raised by Guidant attorneys. The case was brought in Texas state court and filed by two Texas residents who also named a Texas company in the suit, but since the FDA approval has been brought into the case, Guidant attorneys are pushing to have the case moved to Fe...
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3/30/2006 8:05:00 AM | Guidant to withdraw defective stents made for Europe and Japan =(0) Guidant announced the withdrawal of Xience heart stents from the European and Japanese markets after defects were discovered during clinical trials. The company did not disclose the nature of the defects but did note they occurred because of a production problem. They had no reports of injuries to any patients who used the stents, small metal cylin...
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3/29/2006 3:42:00 AM | Medtronic: Guidant infringed on patents =(0) Medtronic has sued Guidant in both Ireland and California, claiming patent infringement with regard to its stent device. A stent is a wire mesh inserted into an artery to keep it open and filter out blood clots which can lead to stroke or heart attack. The stents in question are Guidant's Multi-Link Vision and Xience V. Stock market ...
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3/23/2006 7:07:00 PM | Woman: Failed defibrillator killed spouse =(0) A woman has filed a product liability and wrongful death lawsuit against Guidant Corporation because of a malfunctioning implanted defibrillator that may have killed her husband. Kathleen Gohde was alerted to the problem when while paying final respects to her husband, she heard a beeping sound indicating that the implanted defibrillator was malfun...
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3/14/2006 4:07:00 AM | Bill targets device makers =(0) Rep. Tony Cornish of Minnesota has proposed a bill that would force medical device makers to cover the costs of not only replacement medical devices, in the case of a recall, but also the cost for the surgeries. Currently, in the case of a medical device recall, the manufacturer will replace the device itself, free of charge, but the insurance comp...
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