CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report
Inspira AIR Balloon Dilation system recalled by Acclarent
Acclarent is recalling Inspira AIR Balloon Dilation system, distributed nationwide in the US. The recall was initiated on 11 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1866-2013
- FDA event ID
- 64625
- Recalling firm
- Acclarent, Menlo Park, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jan 2013
- FDA classified
- 1 Aug 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jan 2013 | Recall initiated by company | |
| 1 Aug 2013 | Classified by FDA | +202 days |
| 7 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Questions about this recall
Is Inspira AIR Balloon Dilation system recalled?
Yes. Acclarent recalled Inspira AIR Balloon Dilation system on 11 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-1866-2013.
Why was it 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.
Which lots are affected?
Product code: BC1640A; All lots manufactured after March 1, 2011
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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