Covidien plc (NYSE:COV) launched a voluntary recall of the entire production lot of its Duet TRS single-use heads for thoracic surgery after the company received reports of 13 serious injuries and 3 deaths following use.
"The company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications," according to a press release.
The recall affects 8 models of straight and articulating Duet cartridges, which are endoscopic stapling systems with preloaded tissue reinforcement material. The cartridges attach to GIA universal stapler handles.
"After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures," said Bryan Hanson, Covidien surgical solutions group president, in prepared remarks. "Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery."
Covidien is working with the FDA and other worldwide regulatory bodies to modify the product’s instructions and warn against using Duet TRS in thoracic procedures. The Mansfield, Mass.-based device maker also placed a hold on its global Duet TRS inventory to conduct relabeling, according to a press release.
"These steps are consistent with our belief that patient safety is a commitment that cannot be compromised," said Hanson. "Patient safety is our first obligation."
Covidien has already sold more than 500,000 Duet TRS units worldwide, and about one-third of those are believed to be for thoracic procedures, according to a press release.
A company spokesman did not immediately return a request for comment.