Covidien said that the Duet TRS Universal Straight and Articulating Single-Use Loading Units, a stapler, had injured a patient after abdominal surgery. The product is typically used in “bariatric surgery procedures such as sleeve gastrectomy and Roux-en-Y Gastric Bypass, as well as general abdominal surgical procedures such as pancreatectomy and hepatic resections,” said Bruce Farmer, a Covidien spokesman, in an email.
In the last nine months that ended June 29, the product line had less than $50 million in revenue, Farmer said.
In January, Covidien had issued a voluntary recall of theDuet TRS Universal Straight and Articulating Single-Use Loading Units in the use of thoracic surgery. At the time, the Mansfield, Massachusetts company had received 13 reports of severe injuries and three deaths, prompting it to conclude that “Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, postoperative complications.”
The announcement of the recall follows two other Covidien recalls in as many months.
[Photo Credit: stock.xchng user svilen001]
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