ISSUE: The cuff inflation line of certain KimVent Microcuff Endotracheal tubes may detach from the tube during use (if pulled, tugged, or excess tube/patient movement occurs). If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.
This recall affects device manufacturing dates November 15, 2013 to October 21, 2014, and distribution dates December 20, 2013 to October 30, 2014.
BACKGROUND: The firm received 19 reports where the device malfunctioned. In most cases the problem was identified immediately, while in other cases, it was identified when ventilator alarms went off. Most patients required reinsertion of endotracheal tubes.
RECOMMENDATION: Halyard Health sent customers an Urgent Voluntary Product Recall. The letter described the product, problem, and actions to be taken. Customers who have this product in their inventory should stop using all unused recalled devices and quarantine them.