Bivona 35W025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312014273), received between Apr 17, 2023 and Apr 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K792035); 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 16, 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.

• MalfunctionApr 17, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE INFORMATION WAS MISLEADING FROM THE WEBSITE AND TECHNICAL SHEETS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751527 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K792035. One submission often covers many models, so check the product and lot details in each record.

• Z-0178-2022 · Aug 9, 2021 · Terminated
  Bivona Uncuffed Wire Endotracheal Tubes,
• Z-0177-2022 · Aug 9, 2021 · Terminated
  Bivona Aire-Cuf Endotracheal Tube