title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Massachusetts Eye and Ear Infirmary, Division of Laryngology, Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Jihad
authors.initials: J
authors.lastname: Achkar
authors.forename: Jayme
authors.initials: J
authors.lastname: Dowdal
authors.forename: Daniel
authors.initials: D
authors.lastname: Fink
authors.forename: Ramon
authors.initials: R
authors.lastname: Franco
authors.forename: Phillip
authors.initials: P
authors.lastname: Song
mesh_terms: D000328:Adult; D004106:Dilatation / Q000009:adverse effects* / Q000379:methods; D004724:Endoscopy / Q000379:methods*; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007829:Laryngostenosis / Q000628:therapy*; D057052:Medical Device Recalls; D014481:United States; D014486:United States Food and Drug Administration