"Defective Medical Devices" archive
Friday 1 December
- Drug Coated Stents Prove Risky (09:27) - In a recent medical study released by the Cleveland Clinic, drug coated stents manufactured by such companies as Boston Scientific and Johnson & Johnson have shown an increased risk for clots. With the older bare metal stents, tissue grows around... | 0 Trackbacks
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Wednesday 25 October
- Safety of Drug Coated Heart Stents Still Up in the Air (08:31) - After the third day of Transcather Cardiovascular Therapeutics show, the results are still mixed regarding the safety of drug coated heart stents. The stents, manufactured by Boston Scientific's Taxus and Johnson & Johnson's Cypher, many experts agreed, there appears to... | 0 Trackbacks
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Thursday 7 September
- Boston Scientific Confirms Increased Risk Linked to its Stent (14:19) - A leading stent manufacturer has admitted that there is an increased clot risk for those with Boston Scientific's cardiac stent. It is the first acknowledgment by a stent maker of an increased risk of the dangerous side effect of stents,... | 0 Trackbacks
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Wednesday 17 May
- Boston Scientific Issues New Warning on Defibrillators (07:25) - Boston Scientific warned doctors that close to 1,000 of its cardiac implantable defibrillators may short circuit and fail to work properly leaving its patients vulnerable to cardiac problems. The company said that it learned of the failures after purchasing Guidant... | 0 Trackbacks
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Monday 1 May
- Defibrillator Malfunctions on the Rise (09:05) - According to a study published in The Journal of the American Medical Association, malfunctions in implantable cardioverter defibrillators, or ICDs, are on the rise. The device is designed to keep the heart pumping properly and efficiently.... | 0 Trackbacks
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Saturday 29 April
- Doctors to Receive Guidelines on How to Handle Defective Defibrillators (08:31) - A group that represents doctors, The Heart Rhythm Society, will publish guidelines to help doctors determine how to respond when a heart defibrillator malfunctions. The publication comes in response to problems experienced by cardiac defibrillator manufacturers,Guidant (recently acquired by Boston... | 0 Trackbacks
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Tuesday 11 April
- First Guidant Defibrillator Trial Postponed (06:52) - The first Guidant defective defibrillator trial has been postponed because one of the witnesses is unavailable due to the Passover holiday. The judge has said that the case will most likely resume in July.... | 0 Trackbacks
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Tuesday 21 March
- Guidant's Own Commission Critical of Flaws (06:20) - An expert panel commissioned by Guidant Corporation to assess its handling of problems with cardiac medical devices cited the company for failure to properly assess patient safety. The commission noted that Guidant's decisions were guided by statistical projections provided by... | 0 Trackbacks
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Tuesday 14 March
- Guidant Issues New Implant Warning (10:04) - According to a report published in the NY Times, Guidant Corporation has issued a warning to doctors about possible battery defects in two of its implantable defibrillator devices. The devices in question, the Contak Renewal 3 RF and Renewal 4... | 0 Trackbacks
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Monday 13 March
- Guidant Corp. Cited by Senate Committee (06:33) - Senate Judiciary Committee Chairman Arlen Specter (R-PA) has introduced legislation that would toughen penalties for companies and their executives who sold products that cause injury or death. Presently, there are only civil penalties for such behavior. In announcing the legislation,... | 0 Trackbacks
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Friday 10 March
- Guidant Consultant Advised Company to Release Defect Data (09:40) - A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically... | 0 Trackbacks
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Wednesday 1 March
- Guidant Officials Worried About Device Defects (10:47) - When Guidant Corp. came under fire last year for not revealing to doctors it's problems with its medical device, it remained positive in its public announcements. But newly released documents show that, inside Indianapolis-based Guidant, executives were struggling to contain... | 0 Trackbacks
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Monday 20 February
- Medical Device Approved in Spite of FDA Objection (09:49) - According to an article in the NY Times, "A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.... | 0 Trackbacks
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- Medtronic Continued Selling Defibrillators in Spite of Failures (09:10) - Medtronic Inc. continued selling flawed cardiac defibrillators for two years after learning that some of them may suddenly quit working, according to company documents filed in a California lawsuit.... | 0 Trackbacks
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Friday 17 February
- Guidant Offer to Fix Heart Stent is Inadquate (09:20) - Guidant Corp.'s program to pay $2,500 to patients to replace a heart device that has had malfunctions is nowhere near sufficient to cover costs of the procedure. The offer covers only about 10% of the cost of the replacement procedure.... | 0 Trackbacks
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Thursday 16 February
- FDA Places New Restrictions on Guidant (09:10) - New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure... | 0 Trackbacks
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Friday 10 February
- Guidant CEO to Receive $1.5Million Bonus. . . For What? (05:52) - Guidant's chief executive will receive a $1.5 million bonus after the acquisition by Boston Scientific is complete, according to documents filed with the U.S. Securities and Exchange Commission. Since June, Guidant has recalled or issued safety advisories on about 88,000... | 0 Trackbacks
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Sunday 5 February
- Boston Scientific's Mea Culpa (10:05) - Now that Boston Scientific, the maker of medical devices, has been publicly chastised by the FDA, its executives have taken a penitential tone. "It's clear we have not done enough to resolve the issues raised by the F.D.A., "a spokesman,... | 0 Trackbacks
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Monday 30 January
- FDA Sends Warning to Boston Scientific (07:10) - Boston Scientific fresh off its acquisition of Guidant Corporation, has been sent a warning letter by the FDA. Federal regulators said they discovered problems in the medical device maker's quality control. FDA officials who announced the warning involving Boston Scientific... | 0 Trackbacks
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Sunday 29 January
- Lawyer Subpoenaed for Guidant Documents (11:45) - An attorney suing Guidant Corporation has been ordered by the Justice Department to turn over the documents he received from the company. The subpoena, part of the federal government's investigation into the Indianapolis-based company, requires Texas attorney Bob Hilliard to... | 0 Trackbacks
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Monday 23 January
- Guidant's Troubles Aren't Over (08:03) - On January 19, 2006, a Texas judge ordered Guidant to hand over internal documents that might show the company continued to sell some of its heart defibrillator models after knowing that the devices might prove faulty. The NY Times reported... | 0 Trackbacks
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Wednesday 28 December
- Guidant Withholds Info About the Dangers of its Defibrillators (13:43) - In documents filed in a Texas lawsuit against Guidant, the manufacturer of implantable defibrillators, the company failed to disclose publicly that Guidant officials had projected that some patients might die because of short circuits in their implantable defibrillator. According to... | 0 Trackbacks
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Thursday 15 December
- Guidant Heart Device Blamed for 3 More Deaths (06:58) - According to an article published in the Minneapolis-St. Paul Business Journal Guidant heart devices have been linked to three new deaths. The information arose out of a Guidant report to the US Food and Drug Administration. The deaths occurred after... | 0 Trackbacks
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