Recall Class: Class I
Date Recall Initiated: January 30, 2012.
Product: Acclarent Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, manufactured between March 2011 and June 2011.
Use: The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways.