Covidien Recalls the Duet TRS for use in Thoracic Procedures

January 29, 2012
By Jasper Ward on January 29, 2012 1:14 PM |

Covideien created the Duet TRS in order to aid physicians with tissue reinforcement when placing staples after surgical procedures. Unfortunately, Covidien has 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. Therefore the Covideien instituted a recall of this product on January 16, 2012.

The Duet TRS was 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. Thus, over 150,000 people worldwide could be in danger from this product.

If you have had any surgical procedures since 2009 to your thoracic cavity, which is the area made up of 12 pairs of ribs that connect in the posterior thorax to the vertebral bodies of the spinal column, you should contact your physician that ordered the surgery and find out if the DUET TRS was used. Here are the following model numbers that are being recalled.

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

If you have any questions about the Duet TRS contact Wade Yeoman at Jones Ward, PLC. He can be reached at 502-882-6000 or at wade@jonesward.com