|Covidien recalled certain models of its Shiley tracheostomy devices--courtesy of Covidien|
Covidien ($COV) voluntarily recalled certain lots of its Shiley tracheostomy devices, responding to reports of volume leakage and disconnection between the inner and outer tubes.
The company notified patients and physicians July 18 that some models of its reusable cannula techs could leak or disconnect while in use, possibly disrupting ventilation and endangering patients. Covidien recalled the 8LPC and 8FEN models of the Shiley tubes, asking physicians to return the techs, and, if a patient is already implanted with one, the company recommends replacing it as soon as possible.
Covidien is providing replacement devices to patients affected by the recall, and the company has made the FDA aware of its action.
This is Covidien's second recall over the past few months, with the company discovering a packaging issue with some of its Roticulator staplers back in May, recalling five models over sterility concerns. Last month, Covidien warned U.K. regulators of possible battery failures in some of its at-home ventilators, but the company didn't issue a recall.
- read Covidien's statement