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.

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.