Global healthcare product provider Covidien, this week announced that it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. 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.
Covidien is working with the FDA and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use. It is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery
The Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide
To view the complete list of recalls, visit the FDA’s website at http://www.fda.gov/Safety/Recalls/ucm288098.htm