Bivona 35W070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312014365), received between Apr 10, 2019 and May 20, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 11856479 ↗
• 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 11856407 ↗
• MalfunctionMay 20, 2021Inflation Problem; Inflation Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: Insufficient Information

  MAUDE report 11856386 ↗
• InjuryApr 26, 2019Inflation Problem; Inadequacy of Device Shape and/or Size; Inflation Problem; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA SMALL DIAMETER AIRE-CUFF WIRE REINFORCED ENDOTRACHEAL TUBE (SILICONE) WAS IN USE WITH A PATIENT FOR DELIVERY OF ANESTHESIA. THE REPORTER STATED THE DEVICE WAS IN USE FOR 15 MINUTES WHEN THE USER NOTED THE PATIENT'S THROAT AREA WAS SWOLLEN AND WAS OBSERVED TO HAVE "LIFE THREATENING" HYPOXIA. SUBSEQUENTLY, THE TUBE WAS REMOVED AND THE INFLATION CUFF WAS FOUND TO ONLY BE PARTIALLY INFLATED (NOT SYMMETRICAL). THE REPORTER ALSO STATED THE CUFF MAY HAVE BEEN PRESSING AGAINST THE TRACHEAL POSTERIOR WALL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Airway Obstruction; Hypoxia; Swelling

  MAUDE report 8557480 ↗
• InjuryApr 10, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA SMALL DIAMETER AIRE-CUF® ORAL / NASAL WIRE REINFORCED TUBE DID NOT INFLATE SYMMETRICALLY DURING USE WITH PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8499884 ↗

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