UK MHRA Finally Issues Alert On Covidien Duet One Month After The Company Contraindicates It

Back in mid January medlatest reported here that Covidien was contraindicating its DUET TRS™ universal straight and articulating single use loading units (SULU) for use in thoracic surgery, and conducting a voluntary recall of products from thoracic units. The stapling evice, despite gaining early popularity among thoracic surgeons has been associated with 3 deaths and 13 serious injuries following use in the thoracic cavity.

Now UK’s MHRA has issued its own alert to UK hospitals, stating that “these stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening postoperative complications.”

Importantly Covidien states that only the Duet TRS™ loading units and only for the use of this product in the thoracic cavity are included in the alert. Other Endo GIA™ families of SULUs are not affected.