Bivona FU14JN55NGA269NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688834447), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJul 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL BIVONA CUSTOMIZED FLEXTEND TRACHEOSTOMY TUBE MEASURED TOO SHORT AND THAT THERE WAS A SHARPER CURVE IN THE TUBE THAN NORMALLY. THE PATIENT WAS REPOSITIONED, AND THE TRACH TUBE WAS REPORTED TO CUT THE AIRWAY OFF LEADING TO THE PATIENT DE-SATURATING. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Airway Obstruction; Low Oxygen Saturation

  MAUDE report 10290771 ↗

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.