Covidien voluntarily recalled eight models of its Duet TRS single-use heads for thoracic surgery after receiving reports of 13 serious injuries and three deaths following use, according to a news release.
Covidien is working with the FDA and other regulatory authorities to modify instructions, and the inventory will go on hold to allow for relabeling.
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Covidien is working with the FDA and other regulatory authorities to modify instructions, and the inventory will go on hold to allow for relabeling.
Related Articles on Medical Devices:
Open Source Robotic Surgery to be Researched at US Universities
US Medical Equipment Entrepreneurs Set to Profit from Developing Countries
Samsung Open to Partnering with Olympus on Medical Devices