Bivona FT21KN40NSE076NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517287431), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K923878); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT HAD TO UNDERGO AN EMERGENCY TRACH CHANGE DUE TO THE PILOT BALLOON LEAKING. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. NO ADDITIONAL ADVERSE AFFECTS TO THE PATIENT, AFTER THE COMPLETION OF THE TRACH CHANGE, WERE REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15339897 ↗
• MalfunctionSep 1, 2022Detachment of Device or Device Component; Gas/Air Leak; Detachment of Device or Device Component; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE'S INFLATION LINE BROKE, CAUSING THE CUFF TO LEAK. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. THE ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336472 ↗
• MalfunctionSep 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TRACH TUBE'S INFLATION LINE WAS LEAKING AT THE FLANGE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.