Covidien ($COV) announced Monday that it is conducting a voluntary recall of all production lots for the Duet TRS with respect to use in the thoracic cavity after reports of 13 serious injuries and three deaths.
The Duet TRS includes a fully integrated tissue reinforcement system to support staple lines in tissues. Since its launch in 2009, more than 500,000 units have been sold worldwide.
The company says it is working with the FDA and other regulatory bodies to modify instructions for use to contraindicate the device in thoracic procedures. It also has placed a hold on its Duet TRS inventory to allow for the relabeling with new instructions for use. "These steps are consistent with our belief that patient safety is a commitment that cannot be compromised," said Bryan Hanson, Covidien surgical solutions group president, in a statement. "Patient safety is our first obligation."
Covidien says about one-third of procedures using the device are for thoracic indications. However, the device will still be used for other indications, including abdominal procedures.
- see the Covidien release