Balloon dilation complication during the treatment of subglottic stenosis: background of the FDA class 1 recall for the 18 x 40-mm Acclarent Inspira AIR balloon dilation system.

OBJECTIVES

Balloon dilation for subglottic stenosis allows for a controlled radial expansion of the airway and is considered superior to older techniques of airway dilation. We report the case of a 39-year-old woman with idiopathic subglottic stenosis who had entrapment of an inflated balloon in her subglottis due to device failure while undergoing balloon dilation of the stenotic area.

METHODS

We present a case report and a review of the literature.

RESULTS

As a result of this and other reported incidents, on March 13, 2012, the US Food and Drug Administration issued a class 1 recall of the 18 x 40-mm Acclarent Inspira AIR Balloon Dilation System (Acclarent Inc, Menlo Park, California).

CONCLUSIONS

This is the first report describing a dislodged inflated balloon in the subglottis as a complication of dilation for idiopathic subglottic stenosis. Awareness of this possibility, as well as preparedness with the proper instruments, is vital for prevention of a catastrophic emergency during an otherwise low-risk procedure.