Covidien (NYSE:COV) discontinued certain Duet TRS single-use surgical stapling systems following reports of patients deaths and injuries.
The medical device company cut the Duet TRS Universal Straight and Articulating Single-Use Loading Units following a single report linking the tissue reinforcement devices to a post-operative injury, according to a press release.
That’s in addition to the 13 serious injuries and 3 patient deaths that earlier this year spurred a recall and FDA warnings of possible mismanagement of the recall.
In January Covidien recalled the entire production lot of its Duet TRS single-use heads for thoracic surgery, modifying the product’s instructions and warning against use in thoracic procedures.
"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," Covidien reported at the time.
The Mansfield, Mass.-based device maker had also placed a hold on its global Duet TRS inventory to conduct the relabeling.
In June the FDA asked Covidien to defend its management of the recall, chiding the device maker for its lack of sufficient documentation and delayed response to adverse event reports, which were first noted more than 2 year prior to the recall.
FDA inspectors conducted an investigation of Covidien’s North Haven, Conn., facility between Jan. 13 and Feb. 9, concluding that the company "failed to document investigations into deaths and serious injuries" that spurred the safety warnings for the Duet TRS devices, which were 1st issued in Japan in March 2011.
That recall and the new notice affect 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.
"The company has concluded that Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications," according to the new statement.
To date Covidien has sold more than 540,000 units worldwide, according to a press release. The company sold less than $50 million worth of the devices in the 9 months ended June 29, 2012, according to a related SEC filing.
Discontinuing the products line is going to hit Covidien’s bottom line, lowering 4th quarter earnings per share by "several cents," the company noted.
Covidien has been the subject of a string of recent recalls, including one announced earlier this week for certain grounding pads contained in ablation device kits after at least 4 patients experienced “serious injuries, burns at the pad site.”
Earlier this month Covidien also recalled certain lots of its cuffed Shiley tracheostomy tubes after receiving reports that the devices malfunctioned during patient ventilation.
Last month the Natick, Mass.-based medical device maker issued a renewed U.K. warning on potential battery defects in certain mobile ventilators used primarily by patients in their homes.
Earlier in July the FDA issued a safety alert after receiving reports of more than 100 adverse events, including 9 patient deaths, that may have been caused by Onyx brain blood vessel plugs made by Covidien subsidiary ev3 Inc.
COV shares lost 2% today, trading at $55.28 as of about 11:50 a.m.
