ISSUE: Acclarent received four reports of incidents, one resulting in patient injury, in which the device has apparently malfunctioned. In each of these cases, 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, causing the balloon to be difficult or impossible to deflate.
BACKGROUND: The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways. On January 31, 2012, Acclarent mailed an Urgent Voluntary Product Recall to affected customers. The letter providee instructions for returning affected products to Stericycle.
RECOMMENDATION: Acclarent recommends customers immediately discontinue use of the Inspira AIR Balloon Dilation System, size 18X40mm (Product Code BC1840A). Customers with questions about this recall can contact Acclarent at 1-866-781-1173.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/13/12 - Recall Notice - FDA ]