Bivona FT19AN35NGE060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517178043), received between May 29, 2020 and Jun 1, 2020 — classified as 2 injuries.

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

• InjuryJun 1, 2020Leak/Splash; Leak/Splash

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM 3.5 MM WAS DISCOVERED ASYMMETRICAL AFTER A PATIENT PRESSURES WHERE DROPPING AND BECAME UNSTABLE WITH VITAL SINGS. DURING THIS EVENT LEAKING AIR WAS DISCOVERED AROUND HER STOMA. BUBBLES WERE COMING OUT OF HER MOUTH AND AIR FELT COMING OUT OF NOSE. ADDING WATER TO THE BALLOON DID NOT RESOLVED THE ISSUES. EMERGENT TRACHEOSTOMY WAS PERFORMED.

  Patient problems: Airway Obstruction; Low Blood Pressure/ Hypotension

  MAUDE report 10106417 ↗
• InjuryMay 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF OF THE CUSTOM SMITHS MEDICAL, TRACH TUBE WAS FOUND ASYMMETRICAL WHICH WAS FOUND AFTER IT WAS NOTED THAT HER PRESSURES KEPT DROPPING AND PATIENT IRRITATION. PATIENT WAS LEAKING AIR FROM HER STOMA. BUBBLES WERE COMING OUT OF HER MOUTH AND AIR COULD BE FELT FROM HER NOSE. ADDITIONAL WATER WAS ADDED TO THE CUFF WITH NO RESOLUTION. THE TRACHS WERE CHANGED EACH TIME TO RESOLVE THE ISSUE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Irritation

  MAUDE report 10103698 ↗

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.