AVANOS 35161Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038351612), received between Aug 17, 2020 and Mar 11, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Disconnection; Disconnection

  MEDWATCH/ FDA USER FACILITY MW REPORT MW5150921 REPORTED, "DURING AN EMERGENCY SITUATION, WHEN UTILIZING THE 3.0 MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS, THE CAP THAT CONNECTS [THE] DEVICE TO THE ARTIFICIAL MANUAL BREATHING UNIT (AMBU BAG) WAS POPPING OFF DURING VENTILATION OF PATIENT. [THE] PATIENT REQUIRED REINTUBATION WITH DIFFERENT ENDOTRACHEAL TUBE TO CONTINUE VENTILATION PROCESS." AN UNSPECIFIED RESPIRATORY PROBLEM, "LIFE THREATENING", WAS NOTED, WHICH REQUIRED INTERVENTION; THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18882359 ↗
• MalfunctionFeb 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FDA USER FACILITY REPORT (B)(4) THE FOLLOWING INFORMATION: "PATIENT IS INTUBATED WITH A 3.0 ETT, TUBE IS SECURE, SEDATION IS ADEQUATE, HOWEVER ANY SLIGHT MOVEMENT OR COUGH CAUSES THE BLUE PIECE OF ETT TO POP OFF THE VENT." NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16309057 ↗
• MalfunctionAug 17, 2020Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) WAS FOUND TO BE KINKED AFTER INTUBATION. IT BECAME DIFFICULT TO MANUALLY VENTILATE THE PATIENT DESPITE CORRECT ETT PLACEMENT BEING CONFIRMED. THE PATIENT WAS EXTUBATED AND REINTUBATED. WHEN THE ETT WAS REMOVED AND REPLACED, IT WAS FOUND TO HAVE A SOFT SECTION PARALLEL WITH WORDS "MICROCUFF." THERE WAS NO REPORTED INJURY.

  Patient problems: Extubate

  MAUDE report 10418006 ↗