Bivona FT20GN60NSA036NRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517235029), received between Sep 25, 2020 and Feb 3, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ONLY INFLATED ONE SIDE OF THE TUBE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441987 ↗
• MalfunctionFeb 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED ONLY ONE SIDE OF CUFF INFLATED. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418853 ↗
• MalfunctionAug 19, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDIAL BIVONA CUFF WAS LEAKING. THERE WAS 1.8 ML OF WATER INSTEAD OF THE REQUIRED 3.4ML.

  Patient problems: Insufficient Information

  MAUDE report 12342757 ↗
• MalfunctionAug 19, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM HAS AN FAULTY TRACH.

  Patient problems: Insufficient Information

  MAUDE report 12342187 ↗
• MalfunctionSep 25, 2020Break; Break

  INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587245 ↗

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.