Acclarent, Inc. – FDA Warning Letter, Feb 22, 2013

On March 20, 2013, the FDA issued a Warning Letter to Acclarent, Inc. following an inspection from January 29 to February 22, 2013, at their Menlo Park, CA facility. The inspection determined that Acclarent manufactures the Inspira AIR Balloon Dilation System, Inspira AIR Balloon Catheter Inflation Device, and Cyclops Multi-Angle Endoscope, which are classified as medical devices.

The Inspira AIR Balloon Dilation System devices were found to be misbranded under section 502(t)(2) of the Act, due to a failure to furnish material or information required by section 519 of the Act and 21 CFR Part 806, specifically regarding Medical Devices; Reports of Corrections and Removals.

A significant violation cited was the failure to report a field correction to the FDA in writing, as required by 21 CFR 806.10(a). This pertained to the Inspira AIR Balloon Dilation System, where the potential for the balloon to not deflate or deflate slowly could lead to airway obstruction. While the 18 x 40 mm size was removed and reported as a Class I recall, Acclarent failed to report additional changes made to the Instructions-For-Use for all device sizes and updated physician training materials, which included a warning about potential airway obstruction.

Acclarent was instructed to take