Bivona FT24JN40NGF089NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887709134826), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation Problem” (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.

• InjuryDec 13, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TIGHT-TO-SHAFT CUFFS WERE NOT FILLING CIRCUMFERENTIALLY. THE EVENT OCCURRED DURING SET UP IN THE NICU (NEONATAL INTENSIVE CARE UNIT) AT THE HOSPITAL. CUFF BALLOON WAS TESTED BEFORE INSERTION. MEDICAL INTERVENTION WAS REQUIRED. PATIENT CHANGED TO A PEDS PLUS TRACH. VENTILATOR SETTINGS WERE INCREASED. PATIENT TAKEN TO THE OR (OPERATING ROOM) FOR A BRONCHOSCOPY. THE OUTCOME OF THE EVENT WAS ONGOING. THERE WAS PATIENT INVOLVEMENT, AND PATIENT HARM/ADVERSE EVENT REPORTED. PATIENT SUSTAINED EXTENSIVE CUFF INJURY.

  Patient problems: Sore Throat

  MAUDE report 20925793 ↗

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.