Bivona 35W060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312014341), received between May 20, 2021 and Apr 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation 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 2 most recent of 2 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 ON THE WEBSITE IS MISLEADING IN A WAY FROM TECHNICAL SHEETS. THE INFORMATION DOES STIPULATE THAT THE CUFF IS AN AIR CUFF, BUT WITH LOW DIAMETER, THE INSTRUCTIONS FOR USE MENTIONS THAT THIS IS A TTS CUFF AND IT MUST BE FILLED WITH WATER AND NOT AIR, WHEREAS FOR THE SIZES FROM 6 AND ABOVE THIS IS AN AIR CUFF MUST BE FILLED WITH AIR. THE SAME INSTRUCTIONS FOR USE ALSO MENTIONS THAT THE SILICONE CUFF FITS FLAT AGAINST THE INNER CANNULA DESPITE THE FACT THAT THERE IS NO INNER CANNULA FOR THESE TUBES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751359 ↗
• MalfunctionMay 20, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES SILICONIZED IS NOT INFLATING SYMMETRIC FULLY IN CUFF. UNKNOWN IF PATIENT ADVERSE EVENTS OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 11856345 ↗

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