AVANOS 35114Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00609038351148), received between Aug 31, 2022 and Jul 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Material Separation

  It was reported that during a dental procedure, the physician observed that the inflation tube had separated from the body of the endotracheal tube. A scratch was noted approximately 2 mm from the separation point. There was no reported harm or injury associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058278 ↗
• MalfunctionJul 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THE VENTILATOR DEPENDENT PATIENT WAS INTUBATED WITH THE ORAL ENDOTRACHEAL TUBE (OETT) ON (B)(6) 2023, IT HAD BEEN IN PLACE FOR 27 DAYS. THE CUFF PRESSURE WAS MEASURED AT 15:00 ON DAY 28 AND WAS NOTED TO BE WELL SECURED (WITH NO DISLODGEMENT OF THE CUFF INFLATION LINE). THE PATIENT¿S PARENT REPORTED THAT AT 16:25 THE CUFF INFLATION LINE HAD DISLODGED; THE NURSE APPROACHED IMMEDIATELY. IT WAS NOT REPORTED WHAT, IF ANY MEDICAL INTERVENTION WAS TAKEN; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17324337 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THE MICROCUFF ENDTRACHEAL TUBE INITIALLY HELD PRESSURE IN THE CUFF, BUT NOT AFTER A WHILE AND IT HAD TO BE "RE-BLOCKED CONSTANTLY". THE ISSUE WAS DISCOVERED DURING USE, THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17261390 ↗
• MalfunctionJun 21, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED DURING USE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17172760 ↗
• MalfunctionAug 31, 2022Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00097 FOR THE SECOND EVENT. IT WAS REPORTED THE "PAEDIATRIC MICROCUFF CUFF [WAS] LOSING VOLUME AND ON REMOVAL" THE CUFF WAS SEEN TO BE SPLIT. THE PATIENT REQUIRED REINTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329520 ↗
• MalfunctionAug 31, 2022Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00096 FOR THE FIRST EVENT. IT WAS REPORTED THE "PAEDIATRIC MICROCUFF CUFF [WAS] LOSING VOLUME AND ON REMOVAL" THE CUFF WAS SEEN TO BE SPLIT. THE PATIENT REQUIRED REINTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329491 ↗