Irish drug and medical device maker Covidien PLC is taking a surgical stapler made at its North Haven plant off the market because of injuries to patients, The Associated Press reports.
The company said it is recalling all Duet TRS Universal Straight and Articulating Single-Use Loading Units, which are to staple tissue together in procedures like bariatric surgeries. Covidien said it received a report that linked the product to an injury after it was used in a patient who had had abdominal surgery.
The company recalled some Duet TRS devices in January because of injuries when it was used in the thoracic cavity and is now discontinuing the device. The company said it sent a letter notifying customers of the recall.
Covidien said the product has a buttress material that is used to reinforce surgical staples and the surrounding tissue. That material was causing injuries to some patients. The company said in January that it received reports that three patients had died and 13 had been seriously injured after thoracic surgeries.
Covidien said it has sold about 540,000 Duet TRS units since the product was launched in 2009.
