Covidien Recalls Duet TRS Device Used in Thoracic Procedures

Covidien Plc said a tissue reinforcement product used in medical staplers has been connected with three patient deaths after use in thoracic surgery. As a result, the company has initiated a voluntary recall for all the production lots of its Duet TRS Universal Straight and Articulating Single Use Loading Units for use in the thoracic cavity.

Ireland-based Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. According to a press release, the company claims that the Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.

The Duet TRS will continue to be used and is safe for other indications, including abdominal procedures, company officials noted.

Launched in 2009, 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. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications.

“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, group president, Surgical Solutions, Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.”

The company is working with the U.S. Food and Drug Administration (FDA) and other global regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Covidien also placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use. Additionally, 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.

“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised,” said Hanson. “Patient safety is our first obligation.”

Customers have been notified of this recall by letter on Jan. 12. Covidien’s U.S. headquarters are in Mansfield, Mass.