By Saabira Chaudhuri
Covidien PLC (COV) is voluntarily recalling its Duet TRS
staplers after receiving one report that links the tissue
reinforcement material to a post-operative injury after abdominal
surgery.
Launched in 2009, the product is a tissue reinforcement system
to support staple lines. To date, Covidien has sold more than
540,000 worldwide.
Covidien on Wednesday said it has stopped manufacturing the
units, after concluding that Duet TRS may have the potential to
injure adjacent anatomical structures, which may result in life
threatening post-operative complications.
The affected product codes range between 4535 to 6048A.
The most recent recall is in addition to one unveiled in January
relating to the contraindication of the device in the thoracic
cavity. At that time, Covidien received reports of 13 serious
injuries and three fatalities following the application of Duet TRS
in the thoracic cavity.
On Wednesday, the company said all Duet TRS products can be
returned by emailing feedback.customerservice@covidien.com or
calling 1-800-722-8772, option 1, to obtain a return goods
authorization prior to returning the affected units.
People can report adverse events or quality problems related to
the product by calling or emailing the Food and Drug
Administration's MedWatch Adverse Event Reporting program.
Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com
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