• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Airway balloon catheter

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 1 Device Recall Airway balloon catheter see related information
Date Initiated by Firm January 30, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 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/
Acclarent, Inc.
1525b Obrien Dr
Menlo Park CA 94025-1463
For Additional Information Contact Nooshin Asbagh
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 2
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 and Original Applicant = ACCLARENT, INC.