Microcuff* Endotracheal Tube for Adults 35218Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00609038352183), received between Sep 20, 2025 and Oct 29, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 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 23410646 ↗
• 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 23410642 ↗
• MalfunctionSep 20, 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. 1ST REPORT 8030647-2025-00082, 2ND 8030647-2025-00083, 3RD 8030647-2025-00084, 4TH 8030647-2025-00085.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104218 ↗
• MalfunctionSep 20, 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. 1ST REPORT 8030647-2025-00082, 3RD 8030647-2025-00084, 4TH 8030647-2025-00085, 5TH 8030647-2025-00086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104217 ↗
• MalfunctionSep 20, 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. 1ST REPORT 8030647-2025-00082, 2ND 8030647-2025-00083, 3RD 8030647-2025-00084, 5TH 8030647-2025-00086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104216 ↗
• MalfunctionSep 20, 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. 1ST REPORT 8030647-2025-00082, 2ND 8030647-2025-00083, 4TH 8030647-2025-00085, 5TH 8030647-2025-00086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23104215 ↗
• MalfunctionSep 20, 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. 2ND REPORT 8030647-2025-00083, 3RD 8030647-2025-00084, 4TH 8030647-2025-00085, 5TH 8030647-2025-00086.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23103391 ↗