Earlier this year, Covidien ($COV) recalled lots of its Duet TRS device for use in the thoracic cavity after it was linked to injuries and three deaths. Now, the company is recalling all 540,000 units of the tech, for any indication, and discontinuing its production.
Duet TRS is a single-use loading unit used to reinforce staple lines in tissues after surgery. Covidien received a report that links the device to post-operative injury, concluding that Duet TRS can damage nearby tissues and lead to life-threatening complications.
Covidien notified its customers on Tuesday, asking them to return all units as soon as possible. The FDA is aware of the voluntary recall, and patients and physicians can report adverse events through its MedWatch program.
The recall and its attendant costs will hit Covidien's pocketbook, too, the company told Reuters, cutting earnings per share from continuing operations by 5 cents to 10 cents for fiscal 2013.
The first Duet recall, launched in January, came after the company received reports of 13 serious injuries and three deaths tied to the device's use in thoracic surgeries. Covidien relabeled the device with a contraindication, but further safety concerns motivated this full-scale recall, the company said.
This is Covidien's third recall in a month's time. Last week, the company voluntarily recalled its DGPHP RFA grounding pads and the Cool-tip RFA electrode kits that use them, warning that faulty foil could burn patients. Before that, Covidien called back some of its Shiley tracheostomy tubes after reports of air leakage, and the FDA tabbed it a Class I recall, the agency's most serious designation.
- read Covidien's statement
- here's Reuters' report