Bivona 35W055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312014334), received between Aug 2, 2019 and Aug 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• MalfunctionAug 6, 2019Crack; Fracture; Inflation Problem; Leak/Splash; Crack; Fracture; Inflation Problem; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA SMALL DIAMETER AIRE-CUF WIRE REINFORCED ENDOTRACHEAL TUBE WAS CRIMPED AND DEFORMED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8865649 ↗
• MalfunctionAug 2, 2019Fracture; Inflation Problem; Leak/Splash; Fracture; Inflation Problem; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CUFF LINE OF A SMITHS MEDICAL PORTEX BIVONA SMALL DIAMETER AIRE-CUF WIRE REINFORCED ENDOTRACHEAL TUBE HAS A CRACK IN IT. THEREFORE, THE DEVICE DOES NOT HOLD ANY PRESSURE OR AIR IN THE CUFF. THE REPORTER STATED THE DEVICE WAS IN USE SINCE (B)(6) 2018, AND JUST NOW STARTED TO LEAK AND DEVELOP A CRACK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8856952 ↗

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