Bivona FT23LN55NGF132NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517369922), received between Mar 13, 2025 and Mar 13, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT THE EYE LOOPS ON A FEW TRACHS TORE. EVENT OCCURRED WHILE IN USE WITH PATIENT. THIS WAS NOT REPORTED TO THE FDA. OPERATOR OF THE DEVICE WAS A LAY USER/PATIENT. EVENT OCCURRED AT HOME. THE ISSUE WAS NOT RESOLVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596183 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT THE EYE LOOPS ON A FEW TRACHS TORE. EVENT OCCURRED WHILE IN USE WITH PATIENT. THIS WAS NOT REPORTED TO THE FDA. OPERATOR OF THE DEVICE WAS A LAY USER/PATIENT. EVENT OCCURRED AT HOME. THE ISSUE WAS NOT RESOLVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596179 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT THE EYE LOOPS ON A FEW TRACHS TORE. EVENT OCCURRED WHILE IN USE WITH PATIENT. THIS WAS NOT REPORTED TO THE FDA. OPERATOR OF THE DEVICE WAS A LAY USER/PATIENT. EVENT OCCURRED AT HOME. THE ISSUE WAS NOT RESOLVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596173 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT THE EYE LOOPS ON A FEW TRACHS TORE. EVENT OCCURRED WHILE IN USE WITH PATIENT. THIS WAS NOT REPORTED TO THE FDA. OPERATOR OF THE DEVICE WAS A LAY USER/PATIENT. EVENT OCCURRED AT HOME. THE ISSUE WAS NOT RESOLVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596168 ↗

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.