INSPIRA AIR BC1440ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031063310), received between Jan 3, 2019 and Jun 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Deflation Problem; Deflation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A TRACHEAL DILATION PROCEDURE, THE 14MM X 40MM INSPIRA AIR BALLOON DILATION SYSTEM (BC1440A / LOT #: UNKNOWN) WOULD NOT DEFLATE. IT WAS REPORTED THAT THERE WAS TROUBLE REMOVING THE BALLOON FROM THE PATIENT¿S AIRWAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 21 JUNE 2021. IT WAS INDICATED THAT THE LOT NUMBER OF THE INSPIRA AIR BALLOON IS NOT KNOWN; THE PRODUCT PACKAGING HAS ALREADY BEEN DISCARDED. THE INFORMATION INDICATED THAT THE INSPIRA AIR BALLOON WAS DIFFICULT TO DEFLATE AND DIFFICULT TO REMOVE. THE PHYSICIAN WAS EVENTUALLY ABLE TO GET THE INSPIRA AIR BALLOON THROUGH THE STRICTURE AND REMOVED IT FROM THE PATIENT¿S AIRWAY WITHOUT REQUIRING ADDITIONAL INTERVENTION. THE AIRWAY DILATION WAS STOPPED AT 14MM; THIS WAS THE LARGEST GOAL FOR THE PROCEDURE. THE REPORTED DEFLATION ISSUE RESULTED IN A SHORT DELAY; THE DURATION OF THE DELAY WAS NOT SPECIFIED / REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037526 ↗
• MalfunctionJan 3, 2019Deflation Problem; Deflation Problem

  ACCLARENT WAS INFORMED ON (B)(6) 2018, OF AN EVENT THAT OCCURRED DURING THE AIRWAY DILATION PROCEDURE ON (B)(6) 2018, INVOLVING THE 14 X 40MM INSPIRA AIR BALLOON DILATION SYSTEM (BC1440A / 180817B-PC). IT WAS REPORTED THAT UPON THE SECOND DILATION, THE INSPIRA AIR BALLOON COULD NOT BECOME FULLY DEFLATED; THIS ISSUE WAS REPORTED TO HAVE OCCURRED OUTSIDE OF THE PATIENT¿S AIRWAY. IT WAS REPORTED THAT THE GUIDE/BALLOON WAS NOT FLUSHED PRIOR TO USE. THE INSPIRA BALLOON WAS REPLACED WITH ANOTHER 14 X 40MM INSPIRA AIR BALLOON AND THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED WITH THE REPLACEMENT DEVICE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE ISSUE. THE INSPIRA AIR BALLOON WAS REPORTED TO HAVE BEEN DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214946 ↗

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-1863-2013 · Jan 11, 2013 · Terminated
  Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
• 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-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-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-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-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-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.