Bivona ZT19GN45ZGZ225NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517200409), received between Aug 4, 2020 and Sep 13, 2022 — classified as 2 malfunctions.

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

• MalfunctionSep 13, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT PRODUCT WAS LABELED AS 45MM, BUT ACTUAL LENGTH IS 54MM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411020 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CUFF COMPONENT OF THE CUSTOM BIVONA TRACHEOSTOMY TUBE WAS DEFECTIVE. THE EXACT NATURE OF THE DEFECT WAS NOT STATED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363356 ↗

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.