Bivona ST19JN80NSC109NRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517208917), received between Jun 10, 2021 and Jan 10, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS ASPIRATION OF WATER FROM THE CUFF INTO THE AIRWAY. PRODUCT FAULT OCCURRED WHILST IN SITU IN PATIENT AIRWAY. THE OUTCOME OF THE EVENT WAS AN INTERVENTION BY INTENSIVE CARE CONSULTANT. TRACHEOSTOMY TUBE CHANGED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125174 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT, "WE HAVE SOME BESPOKE TRACHE TUBES THAT HAVE EXPERIENCED CUFF FAILURE - THIS HAS HAPPENED ACROSS TWO TUBES. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT BUT DIDN'T CONTRIBUTE TO PATIENT OR CLINICAL INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118354 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT, "WE HAVE SOME BESPOKE TRACHE TUBES THAT HAVE EXPERIENCED CUFF FAILURE - THIS HAS HAPPENED ACROSS TWO TUBES. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT BUT DIDN'T CONTRIBUTE TO PATIENT OR CLINICAL INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118142 ↗
• InjuryJun 10, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM CUFF DEFLATED WHEN PLACED IN PATIENT WITH 9 ML FILLED AND WHEN THE PARENT ADMINISTERED NEBULIZER, THEY HEARD LEAKING SOUND, SO TUBE CHANGE OUT WAS REQUIRED WITH NO FURTHER ADVERSE PATIENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975012 ↗
• InjuryJun 10, 2021Gel Leak; Gel Leak

  ADDITIONAL INFO RECEIVED 19 MAY 2021: ADDITIONAL FILE NEEDED. SAME ISSUE, SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11974795 ↗

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.