Microcuff* Endotracheal Tube for AdultsRecalls & reported problems across all models
Avanos Medical, Inc. · 8 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 102
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 8 models of Microcuff* Endotracheal Tube for Adults by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between May 28, 2020 and Jun 12, 2026 — classified as 13 injuries, 89 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (30 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Microcuff* Endotracheal Tube for Adults problems
Device problems
- Gas/Air Leak30
- Burst Container or Vessel22
- Pressure Problem16
- Material Twisted/Bent13
- Material Integrity Problem11
- Disconnection10
- Migration or Expulsion of Device7
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Insufficient Information19
- No Known Impact Or Consequence To Patient16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Low Oxygen Saturation4
- Cardiac Arrest2
- Bradycardia1
- Low Blood Pressure/ Hypotension1
Microcuff* Endotracheal Tube for Adults models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Microcuff* Endotracheal Tube for Adults 35216Tube, tracheal (w/wo connector)39 reports
- Microcuff* Endotracheal Tube for Adults 35215Tube, tracheal (w/wo connector)38 reports
- Microcuff* Endotracheal Tube for Adults 35218Tube, tracheal (w/wo connector)10 reports
- Microcuff* Endotracheal Tube for Adults 35214Tube, tracheal (w/wo connector)9 reports
- Microcuff* Endotracheal Tube for Adults 35211Tube, tracheal (w/wo connector)3 reports
- Microcuff* Endotracheal Tube for Adults 35212Tube, tracheal (w/wo connector)1 report
- Microcuff* Endotracheal Tube for Adults 35213Tube, tracheal (w/wo connector)1 report
- Microcuff* Endotracheal Tube for Adults 35217Tube, tracheal (w/wo connector)1 report
Recent Microcuff* Endotracheal Tube for Adults adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Obstruction of Flow
IT WAS REPORTED: THAT THE TUBE KINKS DURING USE, RESULTING IN COMPLETE OBSTRUCTION SO THAT NO OXYGEN CAN PASS THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25494236 ↗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 ↗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 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 23411301 ↗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 23411298 ↗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 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 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 23410657 ↗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 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- Ballard* Closed Suction System for Adults17 models · 121 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- Cortrak 2 Enternal access device14 models · 164 reports
- NEOMED*24 models · 0 reports · 3 recalls
- ON-Q* Pain Relief System with SELECT-A-FLOW2 models · 94 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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