Bivona FT22BN35NGE072NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517295429), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

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

• InjuryNov 14, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS STATED THAT WHILE IN USE WITH PATIENT THE VENT ALARMED A LEAK, AND IT WAS OBSERVED THAT THERE WAS A TEAR BY THE SHAFT AND FLANGE. THE EVENT HAPPENED AT PATIENT'S HOME, BUT THE OPERATOR OF THE DEVICE WAS A HEALTHCARE PROVIDER. THE ISSUE WAS RESOLVED AFTER THEY CHANGED THE TRACH TO A BACKUP. NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT WAS AN 18-MONTH WHITE, NON-HISPANIC MALE BABY. THE WEIGHT OF THE PATIENT IS 19 LBS. THE DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 20683497 ↗

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.