Class 2 Device Recall Inspira AIR Balloon Dilation system

• Date Initiated by Firm: January 11, 2013
• Date Posted: August 01, 2013
• Recall Status: Terminated on October 25, 2013
• Recall Number: Z-1865-2013
• Recall Event ID: 64625
• 510(K)Number: K090660 K110218
• Product Classification: Bronchoscope accessory - Product Code KTI
• Product: Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
• Code Information: Product code: BC1440A; All lots manufactured after March 1, 2011
• Recalling Firm/ Manufacturer: Acclarent, Inc.; 1525-B O'Brien Dr; Menlo Park CA 94025-1463
• For Additional Information Contact: Steven Tivey; 650-687-6050
• Manufacturer Reason for Recall: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
• FDA Determined Cause: Device Design
• Action: Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
• Quantity in Commerce: 3324
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KTI