Bivona HT18DS50NSB928NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517147735), received between Oct 28, 2021 and Oct 28, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Alarm System” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A TRACH WAS INSERTED IN AUGUST AND WAS FINE AT FIRST BUT DEVELOPED A SLOW LEAK. ANOTHER CUFF WAS PUT IN AFTER THE FIRST ONE, AND SEEMED FINE AT FIRST AS WELL AND THEN LEAKED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12713803 ↗
• InjuryOct 28, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT TRACH WAS INSERTED IN AUGUST AND WAS FINE AT FIRST BUT DEVELOPED A SLOW LEAK. ANOTHER TRACH THAT WAS AVAILABLE WAS CHECKED BEFORE INSERTION AND WAS FOUND TO HAVE A LEAK BUT DUE TO THEM NOT HAVING ANY MORE BACKUP TRACHS, THIS ONE WAS INSERTED INTO THE PATIENT WHILE THEY AWAIT BACKUP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 12713269 ↗
• InjuryOct 28, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE WAS INSERTED IN AUGUST AND WAS FINE AT FIRST BUT DEVELOPED A SLOW LEAK. THE VENT KEPT ALARMING FOR A LEAK FOR ABOUT A WEEK. AROUND THIS TIME, THE PATIENT STARTED TO EXPERIENCE BLEEDING AROUND THE TRACH AREA. PATIENTS MOTHER IS UNSURE IF THIS IS RELATED TO THE ISSUES BUT PATIENT IS STILL BLEEDING AND TWO MORE CUFFS EXPERIENCED PIN HOLE LEAKS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12713052 ↗

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.