Balloon Dilation Complication during the Treatment of Subglottic Stenosis: Background of the FDA Class 1 Recall for the 18 × 40-mm Acclarent Inspira AIR Balloon Dilation System

Abstract

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 × 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.