If you’ve ever had to have a surgery, you know the fear that comes along with it. Will I be ok? Is this the right thing for me to do? What will happen if I have trouble? There are just so many uncertainties, and unfortunately when going under the knife, there is nothing you can do but hope and pray for the best possible outcome.
But, what if you find out that something used in your surgery has been recalled? Sure would make me hesitate the next time I have to have anything done, that’s for sure!
The latest recall is from medical device manufacturer Covidien. They have announced a recall on all lots of its Duet TRS Universal Straight and Articulating Single Use Loading Units. The Covidien tissue reinforcement product, which is applied to a patient at the same time as medical staples, should no longer be used in chest surgeries.
The maker of the device used in thoracic surgery recalled all lots of two product lines after receiving reports of 13 serious post-operative injuries and three deaths, following the surgery.
Covidien issued the voluntary recall earlier last 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.
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.
In a statement, Covidien noted that Duet TRS staples have “the potential to injure adjacent anatomical structures within the thorax” and could cause potentially fatal harm to a patient.
“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 is working with the FDA on labeling changes to note that use of the device is contraindicated in thoracic surgery and will hold all international orders pending the label update, the statement said. They are updating the usage instructions on the Duet TRS so it can be used safely in thoracic surgeries performed on adults and children.
The recall does not affect the staples’ use in other indications, such as in abdominal procedures, the company said.
Approximately one-third of the surgeries where the devices are used are thoracic procedures, the company said.
Covidien, which is based in Dublin, but run from Mansfield, said it had sold 500,000 of the devices since 2009. The company said it’s unclear how many devices will be returned.
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 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).
Check out some of these other recalls as well.