AVANOS 35119Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00609038351193), received between Jan 11, 2023 and Mar 6, 2026 — classified as 2 deaths, 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2026-20001 FOR THE FIRST REPORT. REFER TO 3011270181-2026-20002 FOR THE SECOND REPORT. REFER TO 3011270181-2026-20003 FOR THE THIRD REPORT. IT WAS REPORTED, THE BALLON DID NOT REMAIN INFLATED AND THE PATIENT HAD TO BE REINTUBATED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539482 ↗
• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  CUFF ON ETT BLOWN AFTER INTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129555 ↗
• DeathJan 11, 2023Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL 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 THIS REPORT FOR THE SECOND EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE TWISTED. THE DEVICE WAS NOT REPLACED. THE DEVICE WAS IN USE FOR 78-HOURS. THE PATIENT IS DECEASED. ADDITIONAL INFORMATION RECEIVED 15-DEC-2022 STATED "AFTER SPEAKING TO BOTH THE PICU [PEDIATRIC INTENSIVE CARE UNIT] DIRECTOR AND THE PATIENT SAFETY AND QUALITY NURSE MANAGER FOR THE HOSPITAL, [THE CLINICAL NURSE CONSULTANT (CNC) HAD] BEEN INFORMED THAT [SHE WAS] UNABLE TO PROVIDE THE DATE AND CAUSE OF DEATH AT PRESENT DUE TO ABILITY OF BEING ABLE TO IDENTIFY PATIENT WITH THE INFORMATION ALREADY PROVIDED."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16136860 ↗
• DeathJan 11, 2023Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL 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 3011270181-2023-00002 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE TWISTED/KINKED. IT IS UNSURE IF THE DEVICE WAS REPLACED. THE DEVICE WAS IN USE FOR 24-HOURS. THE PATIENT IS DECEASED. ADDITIONAL INFORMATION RECEIVED 15-DEC-2022 STATED "AFTER SPEAKING TO BOTH THE PICU [PEDIATRIC INTENSIVE CARE UNIT] DIRECTOR AND THE PATIENT SAFETY AND QUALITY NURSE MANAGER FOR THE HOSPITAL, [THE CLINICAL NURSE CONSULTANT (CNC) HAD] BEEN INFORMED THAT [SHE WAS] UNABLE TO PROVIDE THE DATE AND CAUSE OF DEATH AT PRESENT DUE TO ABILITY OF BEING ABLE TO IDENTIFY PATIENT WITH THE INFORMATION ALREADY PROVIDED."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16136842 ↗