Enter the word “Duet” into the search button on Medlatest’s pages and you’ll see a raft of articles relating to the trouble the product line has caused Covidien this year. Now it seems the last straw has been reached as the company has announced that it is not only recalling all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU), but is in fact discontinuing manufacturing of the products.
Back in January there was an understandable hoo haa about the use of Duet TRS in the thoracic cavity, based on reports of 13 serious injuries and 3 fatalities, which resulted in that indication being withdrawn and shelf stock recalled. Now Covidien has received one report that links the Duet TRS tissue reinforcement material to a post-operative injury after abdominal surgery too. This has led the Massachussetts based medtech giant to the conclusion that its product may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications.
The affected product codes and descriptions are as follows:
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
Launched in 2009, the Duet TRS reload is a SULU with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company says it has sold more than 540,000 units worldwide
What happens next? Probably an FDA missive followed in about a month by something from the European regulators. In the meantime Covidien has to lick its wounds, having lost a product sales of which amounted for over $50M in the past year.
Source: Covidien, MassDevice