Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
FDA device recall Z-1862-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- Acclarent, Inc.
- 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.
- Action taken
- 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
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KTI
- Quantity affected
- 625
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Date initiated
- 2013-01-11
- Date posted
- 2013-08-01
- Date terminated
- 2013-10-25
- Location
- Menlo Park, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSPIRA AIR BALLOON DILATION SYSTEM (K110218) | Acclarent, Inc. | 2011-03-31 |
| AIRWAY BALLOON CATHETER INFLATION DEVICE (K090660) | Acclarent, Inc. | 2009-06-12 |