Medical device manufacturer Covidien has announced a recall on all Lots of its Duet TRS Universal Straight and Articulating Single Use Loading Units after receiving more than a dozen reports of serious injuries and three deaths when it was used following thoracic surgery.
Covidien issued the “voluntary recall” earlier this week on the Duet TRS. It said the device should not be used following thoracic surgery. The company believes using this device after a thoracic surgery could cause life-threatening complications. It has received 13 reports of serious injuries and 3 deaths when it was used following these surgeries. The Duet TRS is likely to cause serious injuries to the “adjacent anatomical structures” in the throat when it is used as indicated following a thoracic surgery.
“We are advising our customers that the Duet TRS should not be used in thoracic surgery,” a Covidien spokesperson said in the company’s recall statement.
The company said it is working with health regulators worldwide to update the usage instructions on the Duet TRS so it can be used safely in thoracic surgeries performed on adults and children. Covidien also indicates that it is putting a “hold” on its worldwide inventories of the Duet TRS.
The voluntary recall includes the following Duet TRS devices, according to the company’s release:
- DUET4535 (DUET TRS 45 3.5MM STRAIGHT SULU)
- DUET4535A (DUET TRS 45 3.5MM ARTICULATING SULU)
- DUET4548 (DUET TRS 45 4.8MM STRAIGHT SULU)
- DUET4548A (DUET TRS 45 4.8MM ARTICULATING SULU),
- DUET6035 (DUET TRS 60 3.5MM STRAIGHT SULU),
- DUET6035A (DUET TRS 60 3.5MM ARTICULATING SULU),
- DUET6048 (DUET TRS 60 4.8MM STRAIGHT SULU),
- DUET6048A (DUET TRS 60 4.8MM ARTICULATING SULU).
To compensate for the recall, Covidien said it is providing “alternative tissue reinforcement products” which can be used with the company’s endoscopic staplers in a thoracic surgery. The Duet TRS is designed to be used following a number of surgeries. It is described by Covidien as a “fully integrated tissue reinforcement system to support staple lines in tissues. According to Covidien, about 500,00 Duet TRS devices have been sold worldwide since the products came on the market in 2009. Approximately one-third of the surgeries where the devices are used are thoracic procedures, the company said.