Pacemaker and Defibrillator News

Philips recalls defibrillator units over malfunction risk

September 28th, 2009

Philips Healthcare has announced that it is recalling approximately 5,400 HeartStart FR2+ automated external defibrillator units. The company issued the withdrawal notice over concerns that problems with some defibrillators could cause them to fail in an emergency. More »

Medtronic agrees to $144M defibrillator lawsuit settlement

December 21st, 2007

Medtronic Inc. has announced that it has agreed to settle 2,682 defibrillator lawsuits that have been filed against the company. Medtronic says that it will pay $114 million to settle lawsuits filed over its Marquis line of defibrillators.

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Medtronic trying to block patients? device lawsuits

December 4th, 2007

Medtronic Inc. is trying to stop patients who were injured by the company’s medical devices from suing the company. The company argued before the Supreme Court that Charles Riegel, who was injured who his Medtronic catheter burst during an angioplasty, should be prevented from suing because the device was approved by the Food and Drug Administration. Riegel says that the device contains design flaws and that the instructions on its label are misleading.

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$16.75M settlement in state defibrillator lawsuits

August 30th, 2007

Boston Scientific Corp. has reached a $16.75 million agreement with the attorneys general of 35 states to settle their investigations into problems with cardiac defibrillators made by Guidant Corp. Boston Scientific inherited the legal liability for Guidant’s pacemakers and defibrillators after purchasing the company in April 2006.

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Boston Scientific settles 4,000 defibrillator lawsuits

July 14th, 2007

Boston Scientific has announced that it has agreed pay $195 million to settle about 4,000 lawsuits over defibrillators made by the Guidant Corporation. Guidant was purchased by Boston Scientific in 2006.

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Group files pacemaker and defibrillator lawsuit

June 27th, 2007

A group of patients who used pacemakers or defibrillators has filed a lawsuit against the manufacturers of the devices. The 14 patients claim that devices manufactured by Guidant, Cardiac Pacemakers and Boston Scientific were defective and caused them to be hospitalized.

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Boston Scientific facing 1,175 lawsuits over Guidant devices

March 2nd, 2007

Boston Scientific has announced that it is currently facing at least 1,175 lawsuits over Guidant defibrillators . This number includes more than 1,100 individual lawsuits and about 75 class action suits, according to a regulatory filing with the Securities and Exchange Commission. Boston Scientific purchased Guidant in April 2006.

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Judge orders Medtronic to pay for defibrillator replacements

January 9th, 2007

A Minneapolis judge has ruled that Medtronic must repay health insurers the replacement costs for as many as 25,000 recalled defibrillators. Judge James Rosenbaum says that because private and public insurers, including Medicare, may have paid as much as $30,000 to replace some devices, they are entitled to reimbursement from Medtronic. Patients involved in the defibrillator recall were supposed to have received replacement devices from the company.

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FDA calls for electronic pacemaker and defibrillator system

November 10th, 2006

The Food and Drug Administration says that improvements need
to be made in the way that heart pacemakers and defibrillators, as well as many
other medical devices, are monitored after being put on the market for
patients. The agency has released a 37-page report detailing the changes it considers
necessary to safeguard the health of patients with medical devices.

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FDA plans tougher regulation of medical devices

November 9th, 2006

The Food and Drug Administration says that it will take new steps to improve how it monitors the safety of medical devices, including stents, pacemakers and implantable defibrillators. The agency’s decision comes after a year in which it has seen several high-profile medical device cases in the news, including the Guidant pacemaker recall and recent problems with drug-coated stents.

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