Covidien 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.
“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 of surgical solutions at Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.”
Dublin-based Covidien received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. The company concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.
The affected product codes and descriptions are as follows:
||Duet TRS 45 3.5MM Straight Sulu|
||Duet TRS 45 3.5MM Articulating Sulu|
||Duet TRS 45 4.8MM Straight Sulu|
||Duet TRS 45 4.8MM Articulating Sulu|
||Duet TRS 60 3.5MM Straight Sulu|
||Duet TRS 60 3.5MM Articulating Sulu|
||Duet TRS 60 4.8MM Straight Sulu|
||Duet TRS 60 4.8MM Articulating Sulu|
Covidien said it 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. The company also placed a hold on its Duet TRS inventory 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.
Launched in 2009, the Duet TRS is a single-use loading unit with an integrated tissue reinforcement system to support staple lines in tissues. To date, the company has sold more than 500,000 units worldwide. Covidien reported that approximately one-third of global procedures using Duet TRS are for thoracic indications. The Duet TRS will continue to be used for other indications, including abdominal procedures.
Customers were notified of this recall by letter on Jan. 12.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone:
- Online: www.fda.gov/medwatch/report.htm
- Regular Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-332-0178
- Phone: 800-332-1088