Bivona CMZ3162NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517120806), received between Jan 23, 2018 and Jan 23, 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 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.

• InjuryJan 23, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PORTEX® BIVONA® TRACHEOSTOMY TUBE EXPERIENCED A SLOW LEAK. THE PATIENT WAS NOT VENTILATING AT ALL. THE ISSUE WAS OBSERVED SPONTANEOUSLY BY THE PATIENT'S MOTHER AND A REGISTERED NURSE. THE TRACHEOSTOMY TUBE HAD BEEN USED BEFORE AND WAS CLEANED AT THE PATIENT'S HOME. CUFF PATENCY WAS TESTED PRIOR TO USE, AND THE CUFF WAS FILLED WITH STERILE WATER. THE PATIENT IS VENTILATOR DEPENDENT AND CANNOT BREATHE WITHOUT THE TUBE IN PLACE. THE PATIENT EXPERIENCED DYSPNEA. THE PATIENT WAS THEN BAGGED AND THE TRACHEOSTOMY TUBE WAS REPLACED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Dyspnea

  MAUDE report 7212974 ↗

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.