Bivona CMZ2083NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517118094), received between May 9, 2018 and Jun 20, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE PILOT LINE TO A SMITHS MEDICAL PORTEX BIVONA TRACHEOSTOMY (TRACH) TUBE BECAME BLOCKED. IT WAS NOTED THAT THE PILOT LINE TO THE CUFF WOULD SLOWLY FILL WITH AIR BUT WOULD NOT FILL OR WITHDRAW WITH WATER. SUBSEQUENTLY, THE PATIENT REQUIRED AN EMERGENCY TRACH CHANGE WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: Insufficient Information

  MAUDE report 7622645 ↗
• InjuryMay 9, 2018Inflation Problem; Obstruction of Flow; Inflation Problem; Obstruction of Flow

  INFORMATION WAS RECEIVED INDICATING THAT THE PILOT LINE TO A SMITHS MEDICAL PORTEX® BIVONA TRACHEOSTOMY (TRACH) TUBE BECAME BLOCKED. IT WAS NOTED THAT THE PILOT LINE TO THE CUFF WOULD SLOWLY FILL WITH AIR BUT WOULD NOT FILL OR WITHDRAW WITH WATER. SUBSEQUENTLY, THE PATIENT REQUIRED AN EMERGENCY TRACH CHANGE WITH NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500504 ↗

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.