Microcuff* Endotracheal Tube for Adults 35216Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00609038352169), received between May 28, 2020 and Jun 10, 2026 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Defective Device; Gas/Air Leak; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED: THAT DURING BEDSIDE INTUBATION, THREE DIFFERENT ET (ENDOTRACHEAL TUBE) TUBES WERE FOUND TO BE DEFECTIVE. THE BALLOON ON THE END OF THE TUBE WAS UNABLE TO HOLD AIR ON ALL THREE TUBES. ON THE FOURTH TRY, THE FOURTH ET TUBE WAS SUCCESSFUL.PT: 4582. DEVICE: 2588, 2946, 3023. REFERENCE: MW5187406, MW5187408.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465935 ↗
• MalfunctionJun 10, 2026Defective Device; Gas/Air Leak; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED: THAT DURING BEDSIDE INTUBATION, THREE DIFFERENT ET (ENDOTRACHEAL TUBE) TUBES WERE FOUND TO BE DEFECTIVE. THE BALLOON ON THE END OF THE TUBE WAS UNABLE TO HOLD AIR ON ALL THREE TUBES. ON THE FOURTH TRY, THE FOURTH ET TUBE WAS SUCCESSFUL. PT: 4582. DEVICE: 2588, 2946, 3023. REFERENCE: MW5187406, MW5187407.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465930 ↗
• MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE CUFF "BLEW" POST INTUBATION ON MULTIPLE (FIVE (5)) PATIENTS, ACROSS THREE (3) UNITS AND IN THE EMERGENCY ROOM (ER) IN LESS THAN A TWO-MONTH PERIOD. ALL THE PATIENTS WERE RE-INTUBATED WITHOUT INCIDENT. 5 DIFFERENT REPORTS WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411319 ↗
• MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE CUFF "BLEW" POST INTUBATION ON MULTIPLE (FIVE (5) PATIENTS, ACROSS THREE (3) UNITS AND IN THE EMERGENCY ROOM (ER) IN LESS THAN A TWO-MONTH PERIOD. ALL THE PATIENTS WERE RE-INTUBATED WITHOUT INCIDENT. 5 DIFFERENT REPORTS WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411316 ↗
• MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE CUFF "BLEW" POST INTUBATION ON MULTIPLE (FIVE (5) PATIENTS, ACROSS THREE (3) UNITS AND IN THE EMERGENCY ROOM (ER) IN LESS THAN A TWO-MONTH PERIOD. ALL THE PATIENTS WERE RE-INTUBATED WITHOUT INCIDENT. 5 DIFFERENT REPORTS WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410667 ↗
• MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE CUFF "BLEW" POST INTUBATION ON MULTIPLE (FIVE (5)) PATIENTS, ACROSS THREE (3) UNITS AND IN THE EMERGENCY ROOM (ER) IN LESS THAN A TWO-MONTH PERIOD. ALL THE PATIENTS WERE RE-INTUBATED WITHOUT INCIDENT. 5 DIFFERENT REPORTS WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410654 ↗
• MalfunctionOct 29, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE CUFF "BLEW" POST INTUBATION ON MULTIPLE (FIVE (5) PATIENTS, ACROSS THREE (3) UNITS AND IN THE EMERGENCY ROOM (ER) IN LESS THAN A TWO-MONTH PERIOD. ALL THE PATIENTS WERE RE-INTUBATED WITHOUT INCIDENT. 5 DIFFERENT REPORTS WILL BE SUBMITTED FOR EACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410644 ↗
• MalfunctionAug 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED LEAK IN THE CUFF, DISCOVERED DURING PATIENT USE (MULTIPLE OCCURRENCES). THE ETT TUBE WAS REPLACED. THERE WAS NO REPORTED INJURY. REPORTABLE-WHILE NO HARM OR INJURY WAS REPORTED, ANY COMPONENT THAT IS PART OF THE VENT CIRCUIT (FLEX CONNECTOR, DOUBLE SWIVEL ELBOW, Y-ADAPTER, T-PIECE, ETT ADAPTER, ETC.) BREAKS, CRACKS, OR LEAKS AFTER THE VENT CIRCUIT HAS BEEN ESTABLISHED ON THE PATIENT AND WHICH REQUIRES A REPLACEMENT ETT COULD CAUSE OR LEAD TO A SERIOUS INJURY AND/OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929346 ↗
• MalfunctionDec 3, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED, THERE WAS NO SUCTION (DURING USE), IT WAS DISCOVERED KINKING HAD OCCURRED IN [THE] ORAL PHARYNX; THE PATIENT WAS REINTUBATED. IT WAS ADDITIONALLY REPORTED, A ¿NON-SERIOUS¿ OTHER EVENT(S) OCCURRED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 07NOV2024 REPORTED, IT IS UNKNOWN HOW LONG THE ENDOTRACHEAL TUBE (ETT) WAS IN PLACE PRIOR TO THE TUBE KINKING.

  Patient problems: Insufficient Information

  MAUDE report 20835742 ↗
• InjuryNov 12, 2024Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2024-00117 FOR THE FIRST REPORT FDA USER FACILITY MW REPORT MW5159593 REPORTED, ¿[THE] PATIENT REQUIRED EMERGENT INTUBATION... [THE] TUBE WAS REPLACED DUE TO CUFF LEAKING AIR. PATIENT TO OPERATING ROOM FOR TRACHEOSTOMY¿¿ NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT¿S CARE OR CURRENT CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 20667749 ↗
• InjuryNov 12, 2024Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2024-00118 FOR THE SECOND REPORT. FDA USER FACILITY MW REPORT MW5159592 REPORTED, ¿[THE] PATIENT REQUIRED EMERGENT INTUBATION... [THE] TUBE WAS REPLACED DUE TO CUFF LEAKING AIR. PATIENT TO OPERATING ROOM FOR TRACHEOSTOMY¿¿ NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT¿S CARE OR CURRENT CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 20666184 ↗
• InjuryJan 17, 2024Disconnection; Disconnection

  FDA USER FACILITY MED WATCH REPORT FDA MW (B)(4) REPORTED, "THE 15MM CONNECTOR, WHERE THE VENTILATOR OR O2 [OXYGEN] SOURCE CONNECTS, DISCONNECTS FROM THE NECK OF THE ETT [ENDOTRACHEAL TUBE]. THE 15MM CONNECTOR APPEARS TO BECOME LOOSE FROM THE NECK OF THE ETT WHEN WARMED IN THE AIRWAY. WHEN THIS OCCURS, THE PATIENT IS NOT EFFECTIVELY BEING VENTILATED. AT LEAST ONE PATIENT HAS HAD TO BE REINTUBATED IN ORDER TO CONTINUE VENTILATOR TREATMENT. OVERNIGHT ON [REDACTED DATE], THERE WAS A PATIENT IN THE MEDICAL ICU [INTENSIVE CARE UNIT] WHO CODED POST INTUBATION. WHILE TAKING THE COLORMETRIC OFF AND PLACING THE EMMA [EMERGENCY CAPNOMETER], THE BLUE PIECE JUST POPPED OFF. THE RESPIRATORY THERAPIST WAS ABLE TO GET THE CONNECTOR BACK ON QUICKLY." IT WAS ADDITIONALLY REPORTED, THE EVENT OCCURRED IN THE PATIENT¿S HOSPITAL ROOM AND THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 1 DAY; THE PATIENT'S CURRENT CONDITION WAS NOT REPORTED.

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

  MAUDE report 18530546 ↗
• MalfunctionDec 28, 2023

  RESPIRATORY THERAPY REPORTS PROBLEMS WITH THE AVANOS MICROCUFF ENDOTRACHEAL TUBES, IN ADULT SIZES 6.0MM, 7.5MM, AND 8.0MM. THE 15MM CONNECTOR, WHERE THE VENTILATOR OR O2 SOURCE CONNECTS, DISCONNECTS FROM THE NECK OF THE ETT. THE 15MM CONNECTOR APPEARS TO BECOME LOOSE FROM THE NECK OF THE ETT WHEN WARMED IN THE AIRWAY. WHEN THIS OCCURS, THE PATIENT IS NOT EFFECTIVELY BEING VENTILATED. AT LEAST ONE PATIENT HAS HAD TO BE RE-INTUBATED IN ORDER TO CONTINUE VENTILATOR TREATMENT. OVERNIGHT ON [REDACTED DATE], THERE WAS A PATIENT IN THE MEDICAL ICU WHO CODED POST INTUBATION. WHILE TAKING THE COLORMETRIC OFF AND PLACING THE EMMA, THE BLUE PIECE JUST POPPED OFF. THE RESPIRATORY THERAPIST WAS ABLE TO GET THE CONNECTOR BACK ON QUICKLY.

  Patient problems: Cardiac Arrest

  MAUDE report 18408532 ↗
• MalfunctionMay 3, 2023Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2023-00038 FOR THE SECOND REPORT. REFER TO 3011270181-2023-00039 FOR THE THIRD REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 4100070000-2023-8013 REPORTED, ¿PATIENT INTUBATED. MULTIPLE TIMES DURING THE DAY, THE PATIENT BECAME DISCONNECTED FROM THE VENT. THE VENTILATOR TUBING WOULD SPONTANEOUSLY COME APART FROM THE ENDOTRACHEAL TUBE. UPON FURTHER INVESTIGATION WITH RESPIRATORY THERAPY, IT WAS FOUND THAT THE END OF THE 8.0 TUBE WAS STRETCHED OUT FROM HEAT.¿ THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16860698 ↗
• MalfunctionMay 3, 2023Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2023-00037 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00039 FOR THE THIRD REPORT. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 4100070000-2023-8013 REPORTED, ¿PATIENT INTUBATED. MULTIPLE TIMES DURING THE DAY, THE PATIENT BECAME DISCONNECTED FROM THE VENT. THE VENTILATOR TUBING WOULD SPONTANEOUSLY COME APART FROM THE ENDOTRACHEAL TUBE. UPON FURTHER INVESTIGATION WITH RESPIRATORY THERAPY, IT WAS FOUND THAT THE END OF THE 8.0 TUBE WAS STRETCHED OUT FROM HEAT.¿ THERE WAS NO REPORTED INJURY

  Patient problems: Insufficient Information

  MAUDE report 16860697 ↗
• MalfunctionMay 2, 2023Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2023-00037 FOR THE FIRST REPORT REFER TO 3011270181-2023-00038 FOR THE SECOND REPORT FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT 4100070000-2023-8013 REPORTED, ¿PATIENT INTUBATED. MULTIPLE TIMES DURING THE DAY, THE PATIENT BECAME DISCONNECTED FROM THE VENT. THE VENTILATOR TUBING WOULD SPONTANEOUSLY COME APART FROM THE ENDOTRACHEAL TUBE. UPON FURTHER INVESTIGATION WITH RESPIRATORY THERAPY, IT WAS FOUND THAT THE END OF THE 8.0 TUBE WAS STRETCHED OUT FROM HEAT.¿ THERE WAS NO REPORTED INJURY

  Patient problems: Insufficient Information

  MAUDE report 16857836 ↗
• MalfunctionApr 26, 2023Separation Problem; Separation Problem

  IT WAS REPORTED, "WE TURNED THE PATIENT ON HIS SIDE FOR BODY CARE. THE TUBE TWISTED AND SNAPPED OFF. ACTIVE HUMIDIFICATION WAS CONNECTED" [AT THE TIME THE INCIDENT OCCURRED]. THE PRODUCT WAS IN USE FOR LESS THAN FIVE DAYS. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 5APR2023, REINTUBATION WAS NOT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820263 ↗
• MalfunctionApr 6, 2023Disconnection; Stretched

  PATIENT INTUBATED. MULTIPLE TIMES DURING THE DAY, THE PATIENT BECAME DISCONNECTED FROM THE VENT. THE VENTILATOR TUBING WOULD SPONTANEOUSLY COME APART FROM THE ENDOTRACHEAL TUBE. UPON FURTHER INVESTIGATION WITH RESPIRATORY THERAPY, IT WAS FOUND THAT THE END OF THE 8.0 TUBE WAS STRETCHED OUT FROM HEAT.

  Patient problems: Ventilator Dependent

  MAUDE report 16688932 ↗
• MalfunctionJul 26, 2022Material Integrity Problem; Material Integrity Problem

  THE RESPIRATORY THERAPIST (RT) REPORTED, THE ENDOTRACHEAL TUBE (ETT) CUFF WAS NOTED TO BE ¿BLOWN¿, THE CUFF WAS NOT ABLE TO BE FILLED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105272 ↗
• MalfunctionMay 13, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF SIX REPORTS. REFER TO 3011270181-2022-00028 FOR THE FIRST REPORT. REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT. REFER TO 3011270181-2022-00031 FOR THE FOURTH REPORT. REFER TO 3011270181-2022-00032 FOR THE FIFTH REPORT. REFER TO 3011270181-2022-00033 FOR THE SIXTH REPORT. IT WAS REPORTED THAT THE TUBE POPPED OFF AND THEY HAD TO TAPE THE CONNECTOR TO THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401145 ↗
• MalfunctionMay 7, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SIXTH OF SIX REPORTS. REFER TO 3011270181-2022-00028 FOR THE FIRST REPORT. REFER TO 3011270181-2022-00029 FOR THE SECOND REPORT. REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT. REFER TO 3011270181-2022-00031 FOR THE FOURTH REPORT. REFER TO 3011270181-2022-00032 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE TUBE POPPED OFF; THE THERAPIST STATED THAT THEY HAD TO REPLACE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14331967 ↗
• MalfunctionMay 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FOURTH OF SIX REPORTS. REFER TO 3011270181-2022-00028 FOR THE FIRST REPORT. REFER TO 3011270181-2022-00029 FOR THE SECOND REPORT . REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT . REFER TO 3011270181-2022-00032 FOR THE FIFTH REPORT. REFER TO 3011270181-2022-00033 FOR THE SIXTH REPORT. IT WAS REPORTED THAT THE TUBE POPPED OFF; THE THERAPIST STATED THAT THEY HAD TO REPLACE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291934 ↗
• MalfunctionMay 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIFTH OF SIX REPORTS. REFER TO 3011270181-2022-00028 FOR THE FIRST REPORT. REFER TO 3011270181-2022-00029 FOR THE SECOND REPORT. REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT. REFER TO 3011270181-2022-00031 FOR THE FOURTH REPORT. REFER TO 3011270181-2022-00033 FOR THE SIXTH REPORT. IT WAS REPORTED THAT THE TUBE POPPED OFF; THE THERAPIST STATED THAT THEY HAD TO REPLACE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291881 ↗
• MalfunctionMay 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF SIX REPORTS. REFER TO 3011270181-2022-00028 FOR THE FIRST REPORT. REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT . REFER TO 3011270181-2022-00031 FOR THE FOURTH REPORT. REFER TO 3011270181-2022-00032 FOR THE FIFTH REPORT. REFER TO 3011270181-2022-00033 FOR THE SIXTH REPORT. IT WAS REPORTED THAT THE TUBE POPPED OFF AND THEY HAD TO TAPE THE CONNECTOR TO THE TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291827 ↗
• MalfunctionMay 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF SIX REPORTS. REFER TO 3011270181-2022-00029 FOR THE SECOND REPORT. REFER TO 3011270181-2022-00030 FOR THE THIRD REPORT . REFER TO 3011270181-2022-00031 FOR THE FOURTH REPORT . REFER TO 3011270181-2022-00032 FOR THE FIFTH REPORT. REFER TO 3011270181-2022-00033 FOR THE SIXTH REPORT. IT WAS REPORTED THAT THE CODE PATIENT WAS INTUBATED WITH THE TUBE IN THE EMERGENCY ROOM (ER) AND THE TOP POPPED OFF AS SOON AS THE TUBE WAS PLACED; THE PATIENT WAS BAGGED AND REINTUBATED WITH AN 8.5 ENDOTRACHEAL (ETT). THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291705 ↗