Bivona FT18GN35NGF032NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517157697), received between Jun 18, 2020 and Sep 14, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 16, 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.

• MalfunctionSep 14, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE TRACH STARTED TO DISINTEGRATE IN THE LUMEN. A WHITE SUBSTANCE WAS NOTED TO BE OOZING INSIDE THE LUMEN. THE TRACH HAS SINCE BEEN CLEANED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418187 ↗
• InjuryAug 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PILOT BALLOON OF THE BIVONA TRACHEOSTOMY TUBE WAS LEAKING. THE TRACHEOSTOMY TUBE HAD TO BE CHANGED OUT AS A RESULT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379662 ↗
• MalfunctionJun 18, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION WAS RECEIVED INDICATING THAT THE PILOT BALLOON TO A SMITHS MEDICAL PORTEX BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE WAS NOTED TO HAVE A HOLE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED AND THE ISSUE RESOLVED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171100 ↗

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.