Inspira AIR Balloon Dilation system recallZ-1863-2013 · Acclarent, Inc. · initiated Jan 11, 2013
Class II Terminated All recalls posted in August 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Acclarent, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-1863-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 11, 2013
- Posted by the FDA
- Aug 1, 2013
- Recalling firm
- Acclarent, Inc.
- Quantity
- 2703
- Product code
- KTI
- FDA submissions
- K090660, K110218
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Product description
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Code information (models, lots, serial numbers)
Product code: BC1040A; All lots manufactured after March 1, 2011
Other devices under the same FDA submission
3 devices cleared under K090660, K110218 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INSPIRA AIR BC1040AZAcclarent, Inc. · BRONCHOSCOPE ACCESSORY1 recall0 reports
- INSPIRA AIR BC1440AAcclarent, Inc. · BRONCHOSCOPE ACCESSORY2 reports
- INSPIRA AIR BC0524AZAcclarent, Inc. · BRONCHOSCOPE ACCESSORY1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 64625).
- Z-1860-2013 · TerminatedInspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1861-2013 · TerminatedInspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1862-2013 · TerminatedInspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1864-2013 · TerminatedInspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1865-2013 · TerminatedInspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1866-2013 · TerminatedInspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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