Covidien PLC today voluntarily announced a recall of its Duet TRS single-use tissue reinforcement product after reports that the product "has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications", according to the company.
The Duet TRS cartridge, which contains a tissue reinforcement material applied concurrently with staples in one step, is used with Covidien’s Endo GIA, a laparoscopic stapler. In Covidien's announcement today, the company stated the the Duet TRS has been connected with three patient deaths and 13 serious injuries after use in thoracic surgery. Covidien has sold 500,000 of the Duet TRS devices since the product was introduced in January 2009.
As an editorial note, Covidien must be applauded for voluntarily bringing this issue to light, reflecting the company's appreciation of the importance of patient safety as well as maintaining a "long view" of the company's reputation in the device industry.