A Class I recall has been implemented for the Acclarent Inspira AIR Balloon Dilation System, the U.S. Food and Drug Administration (FDA), just announced. A Class I recall is the agency’s most serious and involves a product, that when used, could lead to serious adverse health consequences, including death.
The defective Acclarent Inspira AIR Balloon Dilation System is 18 by 40 mm. The recall involves devices with product code BC1840A that were manufactured between March 2011 and June 2011.
The Inspira AIR Balloon Dilation System is an airway balloon catheter that is meant to dilate and restore airflow to a patient’s airways. Acclarent identified the potential for the Inspira AIR Balloon Dilation System to not deflate or to deflate slowly, which could result in airway obstruction until the balloon is deflated or removed. Prolonged airway obstruction may prevent adequate blood oxygenation, which could lead to temporary or permanent patient impairment.
To date, Acclarent has received four reports of incidents, one resulted in injury to the patient. In each case, difficulty deflating the balloon occurred after the surgeon pulled against resistance in response to the balloon moving distally during dilation. The force applied to the catheter stretched and narrowed the catheter shaft, which caused the balloon to be difficult or impossible to deflate.
Acclarent, Inc.—located at 1525b Obrien Drive Menlo Park, California, 94025-1463—initiated the recall and also mailed an Urgent Voluntary Product Recall to affected customers (January 31, 2012), providing instructions for returning the recalled device to Stericycle. An attachment to that notification included details and photographs to help customers identify any recalled product in their inventory.
Acclarent said it will refund its customers for the returned, recalled Inspira AIR Balloon Dilation System and can be reached at 1.866.781.1173 or through the customers’ Acclarent Sales Representative.