The U.S. Food and Drug Administration (FDA) announced that Coviden plc initiated a voluntary class II recall of a medical device called the Duet TRS Single Use Loading Unit. This device might cause serious injury or death during surgery in the thoracic area.
The Rottenstein Law Group, a Covidien Duet TRS law firm, compassionately advocates for those who have suffered Covidien Duet TRS side effects. If a Covidien Duet TRS was used in your operation and you believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Covidien Duet TRS recalls and Covidien Duet TRS class action lawsuits.
Covidien Duet TRS Might Cause Serious Injuries and Deadly Side Effects
Surgeons use the Covidien Duet TRS Single Use Loading Unit (SULU) as a kind of cartridge for universal surgical stapler guns to suture organs or blood vessels shut. The Duet TRS comes in various sizes depending on which tissues surgeons intend to staple.
On January 16, 2012, the FDA issued a press release stating that Covidien had initiated a voluntary recall of the following Duet TRS products:
- 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; and
- DUET6048A – DUET TRS 60 4.8MM ARTICULATING SULU.
Covidien discovered that when these units were used in thoracic surgery, they caused 13 injuries and three fatalities. Since Covidien introduced the product in 2009, it has sold as many as 500,000 units, and Covidien believes that one-third of them were used in thoracic (abdominal) procedures. The Duet TRS might injure “adjacent anatomical structures” in a patient’s abdomen, which can lead to deadly post-surgical complications.
Covidien plans on revising the Duet TRS’s instructions to contraindicate its use in thoracic procedures, and it placed a hold on its Duet TRS global inventory until its instructions can be changed.
RLG’s Covidien Duet TRS Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Covidien Duet TRS lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Covidien Duet TRS lawsuit on your behalf if necessary. RLG will also keep you up to date on any Covidien Duet TRS class action lawsuits, FDA Covidien Duet TRS warnings, and additional Covidien Duet TRS FDA recall announcements. If you believe a Covidien Duet TRS harmed you, contact RLG today.