Microcuff* Endotracheal Tube for Adults 35215Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00609038352152), received between Jun 5, 2020 and Nov 13, 2025 — classified as 7 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED: THE PILOT BALLOONS ARE BURSTING, AND THE PATIENT IS LOSING VOLUME WHILE ON A VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550861 ↗
• 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 23411339 ↗
• 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 23411330 ↗
• 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 23410674 ↗
• 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 23410661 ↗
• 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 23410648 ↗
• MalfunctionDec 4, 2024Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  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 3011270181-2024-00128 FOR THE FIRST REPORT, REFER TO 3011270181-2024-00130 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE KINKED IN THE PATIENT¿S AIRWAY/TRACHEA, WHICH WAS DISCOVERED WHEN THEY WERE UNABLE TO PASS THE INLINE SUCTION CATHETER DURING BRONCHOSCOPY AND UNABLE TO PERFORM ROUTINE SUCTIONING. IT WAS ADDITIONALLY REPORTED; THE PATIENT UNDERWENT UNSUCCESSFUL EMERGENCY BRONCHOSCOPIES TO TRY TO FIX THE KINK; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845258 ↗
• MalfunctionDec 4, 2024Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  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 3011270181-2024-00128 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00129 FOR THE SECOND REPORT. IT WAS REPORTED, THE TUBE KINKED IN THE PATIENT¿S AIRWAY/TRACHEA, WHICH WAS DISCOVERED WHEN THEY WERE UNABLE TO PASS THE INLINE SUCTION CATHETER DURING BRONCHOSCOPY AND UNABLE TO PERFORM ROUTINE SUCTIONING. IT WAS ADDITIONALLY REPORTED; THE PATIENT UNDERWENT UNSUCCESSFUL EMERGENCY BRONCHOSCOPIES TO TRY TO FIX THE KINK; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844899 ↗
• InjuryDec 4, 2024Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  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 3011270181-2024-00129 FOR THE SECOND REPORT REFER TO 3011270181-2024-00130 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE KINKED IN THE PATIENT¿S AIRWAY/TRACHEA, WHICH WAS DISCOVERED WHEN THEY WERE UNABLE TO PASS THE INLINE SUCTION CATHETER DURING BRONCHOSCOPY AND UNABLE TO PERFORM ROUTINE SUCTIONING. IT WAS ADDITIONALLY REPORTED, THE PATIENT DEVELOPED A RIGHT-SIDE PNEUMONIA AND UNDERWENT SEVERAL UNSUCCESSFUL EMERGENCY BRONCHOSCOPIES TO TRY TO FIX THE KINK. NO ADDITIONAL INFORMATION CONCERNING THE PATIENT¿S CONDITION OR CARE WERE PROVIDED.

  Patient problems: Pneumonia

  MAUDE report 20844794 ↗
• 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 20835761 ↗
• 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 3011270181-2024-00119 FOR THE FIRST REPORT. FDA USER FACILITY MW REPORT MW5159591 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 20667156 ↗
• 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 3011270181-2024-001120 FOR THE SECOND REPORT FDA USER FACILITY MW REPORT MW5159590 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 20664722 ↗
• InjuryOct 16, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED, THE INTUBATED PATIENT EXPERIENCED POSITIVE END-EXPIRATORY PRESSURE (PEEP) LOSS AND SATURATION DROPS DUE TO 1.5H INTENSIFICATION OF VENTILATION. UPON CLOSER INSPECTION OF THE SETUP, IT WAS FOUND THERE WAS NO FRICTION BETWEEN THE CONNECTOR OF THE TUBE AND THE CONNECTOR OF THE EXTRACTION SYSTEM. ADDITIONAL INFORMATION RECEIVED 30SEP2024 REPORTED, THE CONNECTION WAS NOTICEABLY UN-STABLE, AND IT WAS EXPRESSED THAT, THE DIAMETERS (ID/OD) OF THE COMPONENTS WERE NOT CORRECTLY MATCHED. DUE TO THE ALARM OF THE EVITA MACHINE, THE DISCONNECTION WAS NOTICED IMMEDIATELY, AND THE CONNECTION WAS RE-ESTABLISHED QUICKLY; THE INVOLUNTARY PEEP LOSS/DISCONNECT WAS NOTED AS FUNDAMENTAL.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20464122 ↗
• MalfunctionAug 8, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED 04OCT2024 REPORTED, THE ENDOTRACHEAL TUBE (ETT) HAD BEEN IN PLACE FOR 24 HOURS WHEN IT KINKED IN THE BACK OF THE PATIENT¿S THROAT; THE PATIENT HAD NO SERIOUS COMPLICATIONS AND WAS RELEASED WITH NORMAL PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 19942139 ↗
• MalfunctionAug 8, 2024Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3011270181-2024-00085 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00087 FOR THE THIRD REPORT. REFER TO 3011270181-2024-00088 FOR THE FOURTH REPORT. REFER TO 3011270181-2024-00089 FOR THE FIFTH REPORT. IT WAS REPORTED, THE "BLUE END" FELL OUT AND THE CUFF LEAKED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19942078 ↗
• MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 3011270181-2024-00085 FOR THE FIRST REPORT REFER TO 3011270181-2024-00086 FOR THE SECOND REPORT REFER TO 3011270181-2024-00088 FOR THE FOURTH REPORT REFER TO 3011270181-2024-00089 FOR THE FIFTH REPORT. IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE MEDICAL STAFF WERE UNABLE TO PASS THE SUCTION CATHETER [THROUGH THE ETT], THE PATIENT WAS REINTUBATED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19942046 ↗
• MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3011270181-2024-00085 FOR THE FIRST REPORT REFER TO 3011270181-2024-00086 FOR THE SECOND REPORT REFER TO 3011270181-2024-00087 FOR THE THIRD REPORT REFER TO 3011270181-2024-00089 FOR THE FIFTH REPORT IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE MEDICAL STAFF WERE UNABLE TO PASS THE SUCTION CATHETER [THROUGH THE ETT], THE PATIENT WAS REINTUBATED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19941997 ↗
• MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3011270181-2024-00085 FOR THE FIRST REPORT, REFER TO 3011270181-2024-00086 FOR THE SECOND REPORT, REFER TO 3011270181-2024-00087 FOR THE THIRD REPORT, REFER TO 3011270181-2024-00088 FOR THE FOURTH REPORT. IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE MEDICAL STAFF WERE UNABLE TO PASS THE SUCTION CATHETER [THROUGH THE ETT], THE PATIENT WAS REINTUBATED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19941895 ↗
• MalfunctionJan 18, 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...". IT WAS ADDITIONALLY REPORTED, THE EVENT OCCURRED IN THE PATIENT¿S HOSPITAL ROOM AND THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 1 DAY; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18535598 ↗
• MalfunctionMay 22, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2023-00049 FOR THE SECOND EVENT. REFER TO 3011270181-2023-00050 FOR THE THIRD EVENT. REFER TO 3011270181-2023-00051 FOR THE FOURTH EVENT. IT WAS REPORTED THAT MICROCUFF CUFF LEAKAGE WAS FOUND AFTER INTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973911 ↗
• MalfunctionMay 19, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 3011270181-2023-00048 FOR THE FIRST EVENT. REFER TO 3011270181-2023-00049 FOR THE SECOND EVENT. REFER TO 3011270181-2023-00050 FOR THE THIRD EVENT. IT WAS REPORTED THAT MICROCUFF CUFF LEAKAGE WAS FOUND AFTER INTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968186 ↗
• MalfunctionMay 18, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2023-00048 FOR THE FIRST EVENT. REFER TO 3011270181-2023-00049 FOR THE SECOND EVENT. REFER TO 3011270181-2023-00051 FOR THE FOURTH EVENT. IT WAS REPORTED THAT MICROCUFF CUFF LEAKAGE WAS FOUND AFTER INTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956658 ↗
• MalfunctionMay 18, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2023-00048 FOR THE FIRST EVENT. REFER TO 3011270181-2023-00050 FOR THE THIRD EVENT. REFER TO 3011270181-2023-00051 FOR THE FOURTH EVENT. IT WAS REPORTED THAT MICROCUFF CUFF LEAKAGE WAS FOUND AFTER INTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956635 ↗
• MalfunctionMay 11, 2023Material Integrity Problem; Material Integrity Problem

  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 3011270181-2023-00045 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00046 FOR THE SECOND REPORT . IT WAS REPORTED, THE PHYSICIAN HAD TO CHANGE THE PATIENT¿S TUBE DUE TO THE CUFF BURSTING WHEN INFLATED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915364 ↗
• MalfunctionMay 10, 2023Material Integrity Problem; Material Integrity Problem

  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 3011270181-2023-00046 FOR THE SECOND REPORT, REFER TO 3011270181-2023-00047 FOR THE THIRD REPORT . IT WAS REPORTED, THE PHYSICIAN HAD TO CHANGE THE PATIENT¿S TUBE DUE TO THE CUFF BURSTING WHEN INFLATED. THERE WAS NO REPORTED INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906331 ↗