INSPIRA AIR BC0524AZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705031063089), received between Jul 3, 2023 and Jul 3, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  THE EVENT WAS REPORTED VIA VOLUNTARY MEDWATCH REPORT (MW5118360). A PEDIATRIC PATIENT UNDERWENT DIRECT LARYNGOSCOPY, BRONCHOSCOPY, AND BALLOON DILATION UNDER INTERMITTENT APNEA FOR SUBGLOTTIC STENOSIS. A 5MM X 24MM INSPIRA AIR BALLOON DILATION SYSTEM (BC0524AZ / LOT# UNKNOWN) WAS USED. THE DEVICE INITIALLY FAILED TO INFLATE THE AIRWAY AND THE PATIENT¿S OXYGEN SATURATION BEGAN TO DROP. THE INFLATION DEVICE HAD BEEN ATTACHED TO THE STYLET PORT AND NOT THE BALLOON PORT. THE SOLUTION HAD BEEN IRRIGATED INTO THE PATIENT¿S AIRWAY. THE PATIENT¿S AIRWAY WAS SUCTIONED AND THE PATIENT REQUIRED BAG AND MASK VENTILATION. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypoxia

  MAUDE report 17253213 ↗

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-1861-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
• Z-1866-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
• Z-1860-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
• Z-1864-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
• Z-1862-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
• Z-1865-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
• Z-1863-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.