Tuesday, January 17, 2012

Deaths prompt Covidien to recall stapler, halt use in chest surgery

By Rodney H. Brown

Medical devices company Covidien plc has issued a voluntary recall for all of its Duet TRS single-use stapling heads, and said they shouldn’t be used in their approved indication, thoracic surgery, after reports of 13 injuries and three deaths.

In a release issued Monday, Covidien – which is incorporated in Ireland but maintains its corporate headquarters in Mansfield – said that the “Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.” Details of the injuries or complications were not disclosed. The company said it is working with the U.S. Food and Drug Administration and other regulatory authorities to change the instructions for use of the Duet TRS to say the device should not be used in thoracic procedures in both adults and children.

Covidien (NYSE: COV) has placed a hold on its Duet TRS inventory worldwide so it can relabel them with the new instructions for appropriate use, officials said in the release. The Duet TRS has been on the market for approximately two years, and Covidien has sold more than 500,000 units worldwide, the company stated.

At the end of 2011, Covidien said it plans to spin off its pharmaceuticals business and focus all of its efforts on medical devices and supplies going forward. The pharma business will become its own stand-alone public company. Covidien’s drug business is a large supplier of branded generic pain killers, including acetaminophen and hydrocodone.

In November, Covidien reported it agreed to acquire California medical devices company BARRX Medical Inc. for approximately $325 million. In addition to the $325 million, Covidien could pay unspecified additional earnout payments in the future if Sunnyvale-based BARRX Medical hits certain milestones.