Recall Z-1095-2012 ยท KTI Bronchoscope Accessory
Acclarent, Inc.
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.
| Date | Mar 1, 2012 (initiated Jan 30, 2012) |
| Status | Terminated |
| Reason | Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction. |
| Root 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 rec |
| Quantity | 633 units |
| Distribution | Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM Acclarent, Inc., Mar 31, 2011 |