Covidien Warned on Violations Associated with Patient Deaths

Fri, Jul 06, 2012 02:00 CET

Covidien Plc is under fire from the U.S. Food and Drug Administration (FDA) for failing to quickly address reports of injuries and death linked to its surgical staples, which are used in thoracic surgery.

In January, Covidien said it would recall all lots of its Duet TRS units after receiving reports of 13 injuries and three deaths, according to Reuters. The FDA said that the medical device maker received many complaints over the devices since May 2009 yet failed to act until January. The company also failed to document probes into the serious injuries and deaths, according to Reuters.

"Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," said the agency in a June 14 warning letter sent to Covidien.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

Tags:

Sokolove Law Product Liability unsafe medical device Covidien Covidien Plc Duet TRS units