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| Guidant News |
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We have compiled the latest news on the Guidant recall of heart defibrillator and pacemaker medical devices. All of the news articles on this page require Adobe Acrobat to view. If you or a loved one has been injured by a Guidant device and you would like more information on litigation against the manufacturer, please contact us. |
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| Guidant Owner OKs $195 million settlement Indianapolis Star | July 14, 2007 |
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Boston Scientific Corp.'s Guidant unit agreed to pay $195 million to settle claims it hid defects in its heart defibrillators, the company said. The settlement will resolve more than 4,000 claims filed over Guidant's implantable defibrillators, which customers contend short-circuited from faulty insulation, Boston Scientific officials said in a statement Friday. |
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| Boston Scientific Recalls Some Guidant Heart Devices Washington Post | June 26, 2006 |
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Boston Scientific corp. said on Monday it is recalling certain heart devices because of defects that could lead to a malfunction, sending its shares down more than 5 percent to their lowest point in nearly four years. The medical-device maker said the recall includes some lots of Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers and Ventak Prizm 2, Vitality, and Vitality 2 implantable cardioverter defibrillator or ICDs. |
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| Boston Scientific Devices Woes Grow The Boston Globe | June 23, 2006 |
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A Guidant Corp. implantable heart device may fail about 10 times more often than the company projected last year, according to a US Food and Drug Administration analysis released in a Texas lawsuit. The confidential FDA document, written on June 16, 2005, was unsealed in a product liability lawsuit involving Guidant's defibrillators, $30,000 devices that restart hearts with electrical impulses. |
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| New Guidant Warning Issued Bloomberg News | May 16, 2006 |
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Boston Scientific Corp. said it has warned physicians that another 996 defibrillators made by its Guidant unit may quit prematurely, leaving heart failure patients unprotected from sudden cardiac death. |
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| Reviewers Cite Flaws at Guidant The New York Times | March 21, 2006 |
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An expert panel commissioned last summer by the Guidant Corporation to review its handling of heart device flaws said yesterday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures. |
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| Deposition Sheds Light on Guidant Defibrillator Case Indianapolis Star | February 22, 2006 |
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After a Guidant Corp. defibrillator failed to jolt a Minnesota student's heart back to life during cardiac arrest last year, the victim's doctors demanded an explanation from the Indianapolis medical device maker. It offered one, saying its implantable defibrillator suffered from a short-circuit glitch that the company fixed in 2002 by "rerouting" a wire in the tiny, battery-powered device. A top Guidant executive now tells what that repair entailed: applying some medical glue to the electrical wire. |
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| Guidant Discloses Lawsuit Tally, Says Many More Possible MarketWatch | February 22, 2006 |
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| Medical device maker Guidant Corp. is facing about 145 individual lawsuits, around 60 class-action suits, and could face thousands of additional suits down the road over problems with heart devices that became public last year, according to a regulatory filing made Wednesday. | ||||||||||
| Justice Department Wants Guidant Documents TheStreet.com | January 28, 2006 |
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Here Guidant is all set to be acquired for $27 billion, and the Indianapolis heart-device maker just can't seem to get away from the negative press. The Justice Department has told a Texas lawyer that it wants documents showing Guidant was selling certain defibrillators even though it knew the products might cause problems for patients, according to the Associated Press. |
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| Guidant Woes Mounting: More Device Recalls Boston Herald | January 24, 2006 |
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Guidant yesterday issued an advisory to doctors saying it found 145 problems have been reported out of 16,000 pacemakers, raising the failure rate to a range of 0.31 percent to 0.88 percent from a range of 0.17 percent to 0.51 percent. In addition, the company said that another batch of 54,000 pacemakers may have a problem due to a manufacturing mix-up. About 19,300 of those devices remain implanted. |
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| Guidant Debated Device Peril The New York Times | January 20, 2006 |
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| Six months before the Guidant Corporation publicly disclosed short circuits in its heart devices, a debate may have been going on within the company over whether to alert doctors about such failures, internal company documents released yesterday suggest. | ||||||||||
| Judge to Guidant: Make Device Documents Public The Indianapolis Star | January 20, 2006 |
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| Guidant Corp. lawyers were ordered by a Texas judge Thursday to review and make public many of the 600,000 sealed documents the device maker provided to two patients suing the company over recalled defibrillators, lawyers said. | ||||||||||
| N.Y. Times Sues for Access to Guidant Documents Reuters | January 19, 2006 |
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| The New York Times is scheduled to appear in a Texas courtroom on Thursday to request the release of documents that may show medical device maker Guidant Corp. knew its implantable heart defibrillators had a potentially fatally flaw before selling them, according to a plaintiffs' attorney. | ||||||||||
| Files Show Guidant Foresaw Some Risks The New York Times | December 24, 2005 |
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| Officials of the Guidant Corporation projected in an internal report that some patients might die as a result of short circuits in a company heart device, but it did not publicize the flaw because it apparently viewed the overall failure rate as acceptable, company records filed in connection with a lawsuit show. | ||||||||||
| Guidant Ties More Deaths to Faulty Product Associated Press | December 14, 2005 |
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| Three more patients with recalled defibrillators manufactured by Guidant Corp. have died, bringing the total number of known deaths linked to the faulty products to seven, officials with the troubled medical device maker said. | ||||||||||
| Report: Guidant Settles Defibrillator Case The Indianapolis Star | November 22, 2005 |
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| Indianapolis-based Guidant Corp. will settle a lawsuit over the death of a 21-year old man who used a company-many heart device that failed, Bloomberg News reported today. | ||||||||||
| Guidant Issues Data on Faulty Heart Devices The New York Times | November 10, 2005 |
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| The Guidant Corporation, under scrutiny for failing to alert doctors about critical failures of its heart devices, issued its first report yesterday that showed how many units had malfunctioned in ways that prevented them from working. | ||||||||||
| Guidant Lax on Quality and Records, FDA Finds The Minneapolis Star Tribune | October 28, 2005 |
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Guidant Corp. managers did not ensure the quality of heart-implant devices during manufacturing and didn't quickly warn doctors about software glitches that caused some pacemakers to quit, federal regulators said. Guidant released a 79-page document Thursday that it filed with the Food and Drug Administration that outlines problems found by the agency in an August inspection of the company's plant in Arden Hills. The FDA said that Guidnat lacked an effective quality-control system at all leveles and that its record-keeping was poor, with little accountability for errors. |
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| Guidant to Issue More Data on Device Failures The New York Times | October 28, 2005 |
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| The Guidant Corporation, a maker of defibrillators and pacemakers, said yesterday that it planned to start issuing periodic reports that would highlight for each model the number of confirmed failures that prevented the units from delivering critical patient therapy. | ||||||||||
| Guidant Served with Subpoenas The Indianapolis Star | October 26, 2005 |
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Guidant Corp. said it was served with subpoenas from U.S. Attorney's offices in Boston and Minneapolis seeking documents concerning pacemakers, defibrillators and related products. Indianapolis-based Guidant said the subpoena from the Minneapolis office relates to its Ventak Prizm and Contak Renewal defibrillators, which were among products hit by recall notice in the past several months. |
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| Repeated Defect in Heart Device Exposes a History of Problems The New York Times | October 20, 2005 |
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| It was March in the high desert West but the day felt more like early summer—warm, bright and breezy—as
the young couple rode out on rented mountain bikes along a trail that ran through the majestic red rock
canyons outside Moab, Utah.
The two college students met only a few months earlier, in late 2004. But the couple, Jessica Lemieux and Joshua Oukrop, had talked in recent days about their lives together and marriage. "I told him he had met his match," Ms. Lemieux recalled. "That I had started finishing his sentences for him." It was one of the last things she told him. From behind, where Mr. Oukrop was riding, she heard him call out, "Hold on, I need to..." When she turned, he was already falling backward, the bike tumbling on top of him. She pulled off his helmet. He gasped once, and then he stopped breathing. |
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| FDA: More Guidant Heart Device Failures Reported Fox News | October 13, 2005 |
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| U.S. regulators said Thursday they had received 21 reports of device failures, including three deaths, linked to some Guidant Corp. implanted heart defibrillators as of October 7. | ||||||||||
| Guidant Case May Involve Crime Inquiry The New York Times | September 29, 2005 |
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| Criminal investigators at the Food and Drug Administration have apparently become involved in the agency's inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators. | ||||||||||
| Guidant Paid Doctors to Use Its Devices Reuters | September 27, 2005 |
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| In a blurring of the line between medical research and product promotion, Guidant Corporation paid doctors for implanting its cardiac devices, the New York Times and Wall Street Journal said on Tuesday. | ||||||||||
| Implant Program for Heart Devices Was a Sales Spur The New York Times | September 27, 2005 |
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By January, about 80 cardiologists nationwide completed an evaluation run by the Guidant Corporation of one of its products, an improved electrical component, known as a lead, that connects an implanted cardiac device to the heart. In exchange for implanting the lead in three patients and completing five survey forms, each physician received $1,000 from Guidant. |
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| Guidant Recalls More Pacemakers BusinessWeek | September 22, 2005 |
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| Guidant Corp. said Thursday it recalled some of its top-selling Insignia and Nexus implantable pacemakers because of failures, including nine cases requiring emergency hospitalization. | ||||||||||
| FDA to Inspect Guidant Plants Pioneer Press | August 25, 2005 |
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| Federal investigators could be "weeks or months" away from concluding their investigation of Guidant Corp.'s recent recalls of potentially defective implantable defibrillators and pacemakers. | ||||||||||
| FDA Will Not Release Some Data on Heart Devices The New York Times | August 6, 2005 |
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| The Food and Drug Administration said yesterday that it would not release information that it receives annually from the makers of heart devices detailing how often and why products fail. The agency called such data a corporate trade secret. | ||||||||||
| Defibrillator Back on Market CBS News | August 2, 2005 |
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| Guidant Corp. waited five weeks for the Food and Drug Administration to allow its top-selling cardiac defibrillator to return to the market. It may take longer for the company to persuade patients that its products are safe and reliable. | ||||||||||
| Warning Issued for Guidant Device Fix The Indianapolis Star | July 23, 2005 |
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| In another quality-control stumble, Guidant Corp. revised one of its defibrillator recall advisories Friday, saying the recommended fix actually could worsen risks for some patients. | ||||||||||
| Senator Seeks FDA Reports on Guidant Devices The Indianapolis Star | July 20, 2005 |
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The chairman of the Senate Finance Committee has begun looking into the pacemaker and defibrillator recalls issued over the past two months by Guidant Corp. Sen. Charles E. Grassley, R-Iowa, sent a letter to the acting commissioner of the Food and Drug Administration late Monday asking for information about the implantable defibrillators and pacemakers involved in the recalls. |
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| Pacemakers by Guidant Have Flaw The New York Times | July 19, 2005 |
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| The Guidant Corporation, already embroiled in controversy over recalls of heart devices, alerted doctors yesterday that nine of its older pacemaker models are prone to failing. Some patients might need to have the units replaced, the comany said. | ||||||||||
| Guidant Recall Gets Highest Priority The Indianapolis Star | July 1, 2005 |
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The Food and Drug Administration gave 20,600 Guidant Corp. cardiac defibrillators the highest recall priority today. "Malfunctions of these devices can lead to serious consequences, and it's important for patients to call their doctor for additional information and personalized advice," Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said in a statement. |
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| Guidant Issues New Warning on Heart Device The New York Times | June 24, 2005 |
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| The Guidant Corporation, already under scrutiny for delaying disclosures about flawed products, urged doctors today to stop implanting its most sophisticated heart devices because of a fault that might cause some of the 40,000 that have already been implanted to fail. | ||||||||||
| Guidant Press Release Guidant Corporation | June 24, 2005 |
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| Guidant Corporation said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. At this time, Guidant is in the very early stages of a diligent evaluation of the component failure described below. | ||||||||||
| 50,000 Internal Defibrillators Flawed, Recalled The Arizona Republic | June 18, 2005 |
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A company under fire for not telling heart patients about a problem with its implanted defibrillators said Friday that 50,000 of the devices could be flawed and offered to replace more than half of them. At least two patients with defibrillators made by Guidant Corp. have died, and the company said its devices had failed at least 45 times. |
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| FDA Recalls Guidant Defibrillators CBS News | June 17, 2005 |
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| The U.S. Food and Drug Administration will recall more than 38,000 faulty cardiac defibrillators implanted in patients because of potential malfunctions in the devices, the manufacturer Guidant Corp. said Friday. | ||||||||||
| Feds Are Scrutinizing Guidant's Conduct The Indianapolis Star | June 17, 2005 |
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Problems with a popular heart defibrillator have led federal regulators to start an inquiry into whether Guidant Corp. violated a corporate integrity agreement it signed in 2003, the Star Tribune of Minneapolis reported Thursday. Indianapolis-based Guidant had signed the integrity agreement after a former Guidant subsidiary pleaded guilty to felonies and paid $92.4 million to settle criminal and civil charges in a case involving a device meant to treat abdominal aortic aneurysms. |
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| Guidant Recalls Cardiac Defibrillators Yahoo! News | June 17, 2005 |
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| Guidant Corp. on Friday voluntarily recalled nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of potential malfunctions in the devices. The company has offered to replace some of the devices, but has not said that removal or replacement is necessary. | ||||||||||
| Guidant Recalls 50,000 Heart Devices The Indianapolis Star | June 17, 2005 |
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Guidant Corp. today voluntarily recalled nearly 50,000 of its cardiac defibrillators worldwide because of potential malfunctions in the devices. Indianapolis based Guidant said it was advising physicians about the safety of several defibrillator models, which have failed at least 45 times and have caused at least two deaths as recently as May 30. |
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| FDA Issues Nationwide Notification of Recall U.S. Food and Drug administration | June 17, 2005 |
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| FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. | ||||||||||
| Guidant Press Release Guidant Corporation | June 17, 2005 |
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| Guidant Corporation said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant has apprised FDA of these actions, and FDA has indicated that it will classify them as recalls. These communications advise physicians and their patients of safety information and are intended to limited adverse events. Physicians should use this information to decide how best to treat their patients. | ||||||||||
| More News on Guidant Lawsuit | ||||||||||
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