All Articles Tagged With: "Medical Device"
Articles
Judge Rejects Guidant Settlement After Doctors Call For Harsher Punishment
A federal judge has rejected a $296 million plea deal between Guidant and the U.S. government, saying that the settlement fails to properly punish the company for concealing problems with defective defibrillator implants that have been connected to at least six deaths.
Infusion Pump Problems Lead to FDA Initiative to Reduce Risk
Federal regulators have issued new draft guidance aimed at increasing the quality and safety of drug infusion pumps, which have been plagued by defects and recalls in recent years that have resulted in more than 500 deaths.
Covidian Shiley Tracheostomy Tube Recall Issued After 3 Deaths
Covidien is recalling a number of tracheostomy tubes, used to help people breathe on ventilators, due to issues with the tubes leaking. The trach tube problem has resulted in at least 1,200 reported incidents, including at least three deaths.
LIFEPAK 15 Defibrillator Recall: Turns On and Off By Itself
A recall has been issued for the LIFEPAK 15 defibrillator by Physio-Control, Inc. after it was determined that the defibrillators could turn off and on by themselves, potentially resulting in injury or death.
Metal Hip Replacement Problems Being Reviewed in Europe
The United Kingdom’s medical agency will begin reviewing potential problems with metal-on-metal hip implants, due to growing concerns that they may cause non-cancerous tumors, swelling and other hip damage.
Recall for Boston Scientific Defibrillators Lifted, Sales to Resume
The FDA is allowing several heart implants to go back on the market after a temporary recall of Boston Scientific defibrillators was issued last month due to unannounced manufacturing changes.
Guidant Pleads Guilty Over Failure to Disclose Defibrillator Problems
Guidant LLC, a subsidiary of Boston Scientific, has plead guilty to federal charges that it attempted to cover up problems with defective defibrillator implants.
Recall of Boston Scientific Defibrillators Leads to SEC and DOJ Probes
Medical device manufacturer Boston Scientific is facing renewed scrutiny from the federal prosecutors and the Security Exchange Commission (SEC) for an implantable heart defibrillator recall it issued earlier this month after failing to get FDA approval for manufacturing changes.
Tanning Bed Side Effects Lead FDA Panel to Recommend Restrictions
A panel of independent advisors to the FDA is recommending that the federal regulatory agency either ban tanning beds for everyone under the age of 18, or require parental consent. The recommendations are aimed to protect children and teens from UV radiation exposure and the heightened risk of skin cancer from tanning beds.
FDA Warning Letter Over Problems with Stryker Trident Hip Implants Resolved
Stryker Corp. announced this week that it has been declared in compliance with FDA manufacturing standards after more than two years of concerns over operations at one of its medical device plants that manufactured the Stryker Trident hip implant.
