Covidien Plc said a tissue reinforcement product used in medical staplers has been connected with three patient deaths after use in thoracic surgery.
The Duet TRS single-use cartridges, which contain a material that is applied along with staples, should no longer be used in surgeries in patients’ chest cavities, the company said in a statement yesterday. Besides the deaths, Covidien received reports of 13 serious injuries, the company said.
“The company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications,” according to the statement.
Covidien has sold 500,000 of the single-use devices worldwide since January 2009, Marta Newhart, a spokeswoman for the company in Boulder, Colorado, said in a phone interview. The company is recalling those planned for use in thoracic surgery. Covidien doesn’t expect the recall to have a material financial impact, she said.
The Duet TRS cartridge is used with Covidien’s Endo GIA Universal range of laproscopic staplers. The thoracic, or chest, cavity is enclosed by the ribs, the vertebral column and the sternum. It contains the lungs and the heart.
Covidien, which is based in Dublin and run from Mansfield, Massachusetts, received reports of injuries and fatalities “very recently” and “wanted to react very quickly” with the voluntary recall, Newhart said. Only those devices used in thoracic surgeries are being recalled because all of the reported incidents related to this type of surgery, she said.
Products in the company’s inventory will be relabeled with new instructions for use, Covidien said in the statement.