AVANOS 35116Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00609038351162), received between Jul 8, 2022 and Jun 1, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Failure to Advance

  IT WAS REPORTED THAT A REGISTERED NURSE WAS UNABLE TO ADVANCE A SUCTION CATHETER THROUGH THE ORAL ENDOTRACHEAL TUBE (OETT). THE CATHETER WAS ABLE TO PASS BEYOND THE PATIENT'S TEETH (THE PATIENT WAS NOT BITING), BUT ADVANCEMENT WAS OBSTRUCTED IN THE BACK OF HIS THROAT. THE PATIENT WAS EXTUBATED, AND THE OETT WAS CONFIRMED TO BE VISIBLY BENT.

  Patient problems: Insufficient Information

  MAUDE report 25354958 ↗
• MalfunctionMay 21, 2026Material Twisted/Bent

  IT WAS REPORTED, AFTER COMPLETION OF THE PROCEDURE, DURING EXTUBATION OF THE PATIENT THE ENDOTRACHEAL TUBE (ETT) KINKED AND THEY WERE UNABLE TO THE SUCTION PATIENT. TO RESOLVE THE ISSUE, THE RESPIRATORY THERAPIST (RT) PUT THEIR FINGER DOWN THE BACK OF THE PATIENT'S THROAT TO STRAIGHTEN OUT THE KINK; HOWEVER, AS SOON AS SHE REMOVED HER FINGER, IT IMMEDIATELY BENT AGAIN. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25250181 ↗
• MalfunctionSep 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: THE LEAK HAS BEEN FOUND IN SEVERAL FRESHLY OPENED TUBES. THERE WAS NO REPORTED INJURY. THERE WAS THREE DIFFERENT PATIENTS AFFECTED BY THIS ISSUE, THEREFORE 3 DIFFERENT REPORTS WILL BE SUBMITTED. THE 2ND REPORT NUMBER IS 3011270181-2025-20009, AND THE 3RD REPORT IS 3011270181-2025-20011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103390 ↗
• MalfunctionSep 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: THE LEAK HAS BEEN FOUND IN SEVERAL FRESHLY OPENED TUBES. THERE WAS NO REPORTED INJURY. THERE WAS THREE DIFFERENT PATIENTS AFFECTED BY THIS ISSUE, THEREFORE 3 DIFFERENT REPORTS WILL BE SUBMITTED. THE 1ST REPORT NUMBER IS 3011270181-2025- 20008, AND THE 3RD REPORT IS 3011270181-2025-20011.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103388 ↗
• MalfunctionSep 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: THE LEAK HAS BEEN FOUND IN SEVERAL FRESHLY OPENED TUBES. THERE WAS NO REPORTED INJURY. THERE WAS THREE DIFFERENT PATIENTS AFFECTED BY THIS ISSUE; THEREFORE, 3 DIFFERENT REPORTS WILL BE SUBMITTED. THE 1ST RREPORT NUMBER IS 3011270181-2025- 20008, AND THE 2ND REPORT IS 3011270181-2025-20009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103387 ↗
• MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2024-00108 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00109 FOR THE SECOND REPORT. IT WAS REPORTED THE ENDOTRACHEAL (ETT) KINKED AND THE PATIENT REQUIRED RE-INTUBATION; NO PATIENT HARM OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 20475930 ↗
• MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2024-00109 FOR THE SECOND REPORT REFER TO 3011270181-2024-00110 FOR THE THIRD REPORT IT WAS REPORTED THE ENDOTRACHEAL (ETT) KINKED AND THE PATIENT REQUIRED RE-INTUBATION; NO PATIENT HARM OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 20475701 ↗
• MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2024-00108 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00110 FOR THE THIRD REPORT. IT WAS REPORTED THE ENDOTRACHEAL (ETT) KINKED AND THE PATIENT REQUIRED RE-INTUBATION; NO PATIENT HARM OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 20475693 ↗
• MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) SEEMED TO BE KINKED IN THE [PATIENT¿S] OROPHARYNX AND THEY WERE UNABLE TO PASS THE SUCTION CATHETER; THE PATIENT WAS REINTUBATED. IT WAS NOTED THE ETT HAD [PREVIOUSLY] WORKED WELL AND THEY WERE ABLE TO PASS THE SUCTION CATHETER WHEN IT WAS INITIALLY PLACED EARLIER IN THE DAY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20192809 ↗
• MalfunctionMay 8, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED, WHEN THE SYRINGE WAS REMOVED FROM THE MICRO-CUFF THE AIR IN THE CUFF RELEASED.

  Patient problems: Insufficient Information

  MAUDE report 19268636 ↗
• InjuryMay 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE PATIENT WAS INTUBATED AROUND 2030 THAT EVENING AND BY 0200 WAS SHOWING SIGNS OF A KINKED TUBE; THE STAFF WAS UNABLE TO PASS CATHETER AND [THE PATIENT] EXPERIENCED HIGH PEEK INSPIRATORY PRESSURE (PIPS). THE PATIENT WAS REINTUBATED, NO KNOWN HARM CURRENTLY.

  Patient problems: Increased Peak Expiratory Flow rate

  MAUDE report 19261136 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2024-00040 FOR THE SECOND REPORT. REFER TO 3011270181-2024-00041 FOR THE THIRD REPORT. A REOCCURRING PROBLEM WAS REPORTED; PER GOOGLE TRANSLATE: "DURING THE SURGICAL BLOCK, AS SOON AS THE INTUBATION TUBE HAS BEEN AT BODY TEMPERATURE, IT BECOMES VERY FLEXIBLE AND FOLDED AT THE CORNERS OF THE LIPS, RESULTING IN AN OBSTRUCTION AND MAKING VENTILATION DIFFICULT. THE PRESSURE BUILD-UP ALARMS ALLOWED US TO QUICKLY REALIZE THE SITUATION." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 04MAR2024 REPORTED, THERE WAS NO REINTUBATION OF THE PATIENT, AND THERE WERE NO REPERCUSSIONS ON THE CHILD¿S CONDITION.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18963374 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2024-00039 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00040 FOR THE SECOND REPORT . A REOCCURRING PROBLEM WAS REPORTED; PER GOOGLE TRANSLATE: "DURING THE SURGICAL BLOCK, AS SOON AS THE INTUBATION TUBE HAS BEEN AT BODY TEMPERATURE, IT BECOMES VERY FLEXIBLE AND FOLDED AT THE CORNERS OF THE LIPS, RESULTING IN AN OBSTRUCTION AND MAKING VENTILATION DIFFICULT. THE PRESSURE BUILD-UP ALARMS ALLOWED US TO QUICKLY REALIZE THE SITUATION." THERE WAS NO REPORTED INJURY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18963351 ↗
• MalfunctionMar 22, 2024Material Deformation; Material Deformation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 3 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2024-00039 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00041 FOR THE THIRD REPORT. A REOCCURRING PROBLEM WAS REPORTED; PER GOOGLE TRANSLATE: "DURING THE SURGICAL BLOCK, AS SOON AS THE INTUBATION TUBE HAS BEEN AT BODY TEMPERATURE, IT BECOMES VERY FLEXIBLE AND FOLDED AT THE CORNERS OF THE LIPS, RESULTING IN AN OBSTRUCTION AND MAKING VENTILATION DIFFICULT. THE PRESSURE BUILD-UP ALARMS ALLOWED US TO QUICKLY REALIZE THE SITUATION." THERE WAS NO REPORTED INJURY.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18963343 ↗
• MalfunctionDec 5, 2023Backflow; Backflow

  IT WAS REPORTED, WATER WAS IN THE CUFF, BUT NO LEAKAGE; THERE WAS NO REPORTED MEDICAL INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18267165 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2023-00103 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00108 FOR THE SECOND REPORT. 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 17261306 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2023-00103 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00109 FOR THE THIRD REPORT. 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 17261288 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2023-00108 FOR THE SECOND REPORT REFER TO 3011270181-2023-00109 FOR THE THIRD REPORT 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 17260491 ↗
• MalfunctionJul 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE MICROCUFF ENDOTRACHEAL TUBE (ETT), SIZE 5.5 STRAIGHT KINKED INTRA-ORALLY PREVENTING VENTILATION; VENTILATION WAS ESTABLISHED WITH A DIFFERENT ETT TUBE. NO REPORTED INJURY.

  Patient problems: Hypoventilation

  MAUDE report 14961090 ↗