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 [email protected] 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 [email protected]
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