Justice Department Fines Medical Device Makers over $110 Million
The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 billion in judgments and settlements. Fines against medical device makers totaled over … [Read more...] about Justice Department Fines Medical Device Makers over $110 Million
20 Insurers Sue Over Defective Defibrillators
Defective Guidant Defibrillators Injury Lawsuits. When countless Southwest Florida heart patients received a letter last year informing them that their Guidant defibrillators were defective, they rushed to their doctors hoping for a replacement. But, they’ve learned that changing the devices can be even more … [Read more...] about 20 Insurers Sue Over Defective Defibrillators
Guidant cautions doctors to check some defibrillators
Check the voltage on certain implantable defibrillators, Guidant asks. Guidant Corp., which is being acquired for $27 billion by Boston Scientific Corp., cautioned doctors Monday to check the voltage on certain implantable defibrillators after the company received several reports of defective devices. The … [Read more...] about Guidant cautions doctors to check some defibrillators
KEY DATES IN GUIDANT’S STRUGGLE
Ventak Prizm 2 DR Model 1861 implantable defibrillator tagged in patient death. May 25, 2005: Guidant Corp. reports 26 cases of failure, including the death of a young Minnesotan — from its Ventak Prizm 2 DR Model 1861 implantable defibrillator. The advisory coincides with a New York Times article saying the company waited years to … [Read more...] about KEY DATES IN GUIDANT’S STRUGGLE
Guidant exec says FDA incorrectly told about defibrillator fixes
Defibrillator Implicated In Patients' Deaths. Medical device maker made changes to one of its defibrillators. A Guidant Corp. executive acknowledged the medical device maker made changes to one of its defibrillators in 2002 and later incorrectly told federal regulators it had no effect on the product's … [Read more...] about Guidant exec says FDA incorrectly told about defibrillator fixes
Ex-worker says Guidant pushed speed over quality
Troubled factory making … [Read more...] about Ex-worker says Guidant pushed speed over quality
Guidant Voluntarily Recalls Artery Stent
Indianapolis-based medical device maker is recalling certain lots of its three millimeter-diameter Multi-Link Vision stent. Guidant Corp. has begun a voluntary, partial recall of a stent that won federal approval less than three months ago, the company disclosed Wednesday. The Indianapolis-based medical device maker is recalling … [Read more...] about Guidant Voluntarily Recalls Artery Stent
Guidant Required To Have Monitor
Federal officials will require medical-device giant Guidant to undergo outside monitoring. Federal officials will require medical-device giant Guidant to undergo outside monitoring to make sure its Menlo Park subsidiary reports any more problems with a medical device that was linked to 12 deaths. Under the "corporate integrity … [Read more...] about Guidant Required To Have Monitor
