Bivona ST16GN90NSC105NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517064698), received between Oct 20, 2017 and Oct 20, 2017 — 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 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.

• InjuryOct 20, 2017Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® CUSTOM TRACHEOSTOMY TUBE WAS ASYMMETRICAL. THE PATIENT'S VENTILATOR WENT INTO APNEA MODE DUE TO THE LEAK, AND AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS PERFORMED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Apnea

  MAUDE report 6966328 ↗

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.