Bivona 35W040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312014303), received between Jun 26, 2019 and May 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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.

• MalfunctionMay 19, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES SILICONIZED CUFF OVERSTRETCHES AND CANNOT BE BLOCKED. UNKNOWN IF ANY PATIENT ADVERSE EVENTS OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 11852707 ↗
• MalfunctionJun 26, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA SMALL DIAMETER TTS AIRE-CUF ORAL/NASAL WIRE REINFORCED TUBE (SILICONE) CUFF WOULD NOT INFLATE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8733175 ↗

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