INSPIRA AIR BC1040AZRecalls & reported problems
Acclarent, Inc. · INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK · Class 2
All models of INSPIRA AIR (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K090660); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Apr 4, 2025Class IIOpen, Classified
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Z-1724-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090660. One submission often covers many models, so check the product and lot details in each record.
- Z-1862-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1860-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1863-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1864-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1866-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1861-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1865-2013 · Jan 11, 2013 · TerminatedInspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Other BRONCHOSCOPE ACCESSORY devices
- ViziShot 2 FLEX NA-U403SX-4019Gyrus ACMI, LLC · Bronchoscope accessory1 recall349 reports
- PeriView FLEX NA-403D-2021Gyrus ACMI, LLC · Bronchoscope accessory54 reports
- CRE Pulmonary M00550340Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY26 reports
- CRE Pulmonary M00550310Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY21 reports
- CRE Pulmonary M00550350Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY21 reports
- CRE Pulmonary M00550330Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY20 reports
- CRE Pulmonary M00550320Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY15 reports
- CRE Pulmonary M00550300Boston Scientific Corporation · BRONCHOSCOPE ACCESSORY12 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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