Boston Scientific, Guidant to pay $30M settlement

October 17, 2013

The Justice Department says Boston Scientific Corp. and its Guidant subsidiaries will pay $30 million to settle allegations that Guidant knowingly sold defective heart devices that health care facilities implanted in Medicare patients from 2002 to 2005.

Boston Scientific is headquartered in Natick, Mass., and acquired Guidant in 2006.

The Justice Department says that while Guidant took corrective action to fix the defects, the company continued selling its remaining stock of defective versions of the devices. In addition, the government alleged that as Guidant learned about the cause of the defect, it took steps to hide the problem from patients, doctors and the Food and Drug Administration, which regulates medical devices.

The devices are used in patients at risk of cardiac arrest due to an irregular heartbeat.

Explore further: US approves less-invasive heart defibrillator

Related Stories

US approves less-invasive heart defibrillator

September 29, 2012

(AP)—The U.S. Food and Drug Administration says it has approved a first-of-a-kind heart-zapping implant from Boston Scientific that that does not directly touch the heart.

FDA proposes new rules for heart defibrillators

March 22, 2013

(AP)—The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.

FDA requires tracking codes on medical implants

September 20, 2013

Federal health regulators will begin tracking millions of medical devices, from pacemakers to hip replacements, using a new electronic system designed to protect patients by catching problematic implants earlier.

Research will 'revolutionize implantable device therapy'

October 11, 2013

(Medical Xpress)—Although an irregular heartbeat is a common malady in the United States, affecting an estimated 5 million people, the treatments for it are limited in scope and effectiveness. Now, Igor Efimov, PhD, at ...

Recommended for you

Amyloid-related heart failure now detectable with imaging test

August 24, 2016

A type of heart failure caused by a build-up of amyloid can be accurately diagnosed and prognosticated with an imaging technique, eliminating the need for a biopsy, according to a multicenter study led by researchers at Columbia ...

Biomarkers may help better predict who will have a stroke

August 24, 2016

People with high levels of four biomarkers in the blood may be more likely to develop a stroke than people with low levels of the biomarkers, according to a study published in the August 24, 2016, online issue of Neurology, ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.