US FDA raps Covidien over Duet recall
This article was originally published in Clinica
The US FDA has cracked down on Covidien over the way it handled the recall of its Duet TRS tissue reinforcement system. The company had alerted doctors in January not to use the surgical stapling device in thoracic surgery, after receiving reports of three deaths and 13 serious injuries (www.clinica.co.uk, 18 January 2012). Covidien did not recall the device for other uses, including abdominal surgery.