Class 1 Device Recall Airway balloon catheter

• Date Initiated by Firm: January 30, 2012
• Date Posted: March 01, 2012
• Recall Status: Terminated on August 29, 2013
• Recall Number: Z-1095-2012
• Recall Event ID: 61070
• 510(K)Number: K110218
• Product Classification: Bronchoscope accessory - Product Code KTI
• Product: Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree.
• Code Information: Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.
• Recalling Firm/ Manufacturer: Acclarent, Inc.; 1525b Obrien Dr; Menlo Park CA 94025-1463
• For Additional Information Contact: Nooshin Asbagh; 650-687-5398
• Manufacturer Reason for Recall: Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
• FDA Determined Cause: Component design/selection
• Action: Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales Representative.
• Quantity in Commerce: 633 units
• Distribution: Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, 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