Medical Device Safety and Recalls: Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes - Component May Detach During Use

A recall has been issued for Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes.  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.

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.

Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm428617.htm


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