Bivona FT18GN50NGF034NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517157666), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF WOULD NOT HOLD WATER. THE PATIENT WAS NOT ABLE TO HOLD VOLUMES ON VENTILATOR SO THE TRACH WAS REMOVED. IT WAS PLACED IN A BAGGIE AND THE CUFF WAS FILLED WITH SALINE. THE BAGGIE BECAME WET OVER A SHORT PERIOD OF TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774484 ↗

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.