Microcuff* Endotracheal Tube for Adults 35214Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00609038352145), received between Jun 5, 2020 and Jun 12, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 9 most recent of 9 reports, 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 ↗
• InjuryAug 19, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2025-20005 FOR THE FIRST REPORT. REFER TO 3011270181-2025-20007 FOR THE THIRD REPORT . IT WAS REPORTED, THE DOCTOR REINTUBATED THE PATIENT; HOWEVER, AFTER REINTUBATION THE ENDOTRACHEAL TUBE(ETT) CUFF POPPED, WHICH RESULTED IN A DELAY IN TREATMENT FOR THE PATIENT.

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

  MAUDE report 22839809 ↗
• MalfunctionAug 19, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2025-20006 FOR THE SECOND REPORT REFER TO 3011270181-2025-20007 FOR THE THIRD REPORT. IT WAS REPORTED, THE DOCTOR REINTUBATED THE PATIENT; HOWEVER, AFTER REINTUBATION THE ENDOTRACHEAL TUBE(ETT) CUFF POPPED, WHICH RESULTED IN A DELAY IN TREATMENT FOR THE PATIENT AND TRAUMA TO THE PATIENT'S ESOPHAGUS.

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

  MAUDE report 22839808 ↗
• InjuryAug 19, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2025-20005 FOR THE FIRST REPORT. REFER TO 3011270181-2025-20006 FOR THE SECOND REPORT. IT WAS REPORTED, THE DOCTOR REINTUBATED THE PATIENT; HOWEVER, AFTER REINTUBATION THE ENDOTRACHEAL TUBE(ETT) CUFF POPPED, WHICH RESULTED IN A DELAY IN TREATMENT FOR THE PATIENT.

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

  MAUDE report 22839807 ↗
• MalfunctionAug 23, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE TRACHEOSTOMY TUBE KINKED IN THE PATIENTS¿ MOUTH; THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275230 ↗
• MalfunctionJun 5, 2020Gas/Air Leak; Pressure Problem; Gas/Air Leak; Pressure Problem

  USER FACILITY REPORT (B)(4) WAS RECEIVED 12-JUN-2020. DESCRIPTION OF EVENT WAS "PATIENT INTUBATED FOR ANGIOEDEMA. SINGLE ATTEMPT PASSED GENTLY USING GLIDESCOPE HYPERANGULATED BLADE. NOTHING UNUSUAL ABOUT THE INTUBATION. TUBE PASSED EASILY. CUFF HAD IMMEDIATE LEAK. REPLACED OVER BOUGIE EASILY. THIS WAS A 7.5 MICROCUFF ETT [ENDOTRACHEAL TUBE] KEPT BY THE RESPIRATORY THERAPIST. THE TUBE WAS PLACED UNDER WATER AND INFLATED. LEAK APPEARS TO BE IN THE DISTAL CUFF. PILOT BALLOON AND LINE APPEARED UNDAMAGED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10126213 ↗
• MalfunctionJun 5, 2020Gas/Air Leak; Pressure Problem; Gas/Air Leak; Pressure Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2020-00084 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00085 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00086 FOR THE FOURTH REPORT. IT WAS REPORTED THAT "SEVERAL" INCIDENTS OF SUBGLOTTIC ET [ENDOTRACHEAL] TUBE CUFF LEAKS OCCURRED THAT ARE NOTICED VIA CUFF PRESSURE CHECKS "ANYWHERE FROM 2-14 DAYS AFTER INTUBATION." ANESTHESIOLOGIST DOES NOT ALWAYS CHECK ETT [ENDOTRACHEAL TUBE] CUFF PATENCY PRIOR TO INTUBATION. ALL TUBES ARE PLACED VIA VIDEO LARYNGOSCOPE TO CONFIRM CORRECT TUBE PLACEMENT. WHEN CUFF LEAKS ARE NOTICED ALL PATIENTS HAVE REQUIRED REINTUBATION WITHOUT DIFFICULTY. NO PATIENT INJURIES. PATIENT INFORMATION WAS PROVIDED. DATE INTUBATED: (B)(6) 2020, DATE EXTUBATED: (B)(6) 2020, PEEP SETTINGS: 6-16, NO LOT CODE PROVIDED. ADDITIONAL INFORMATION RECEIVED 22-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED THROUGH NORMAL PATIENT MONITORING. THE INCIDENT DID NOT OCCUR DURING SURGERY, DID NOT OCCUR DURING T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10126209 ↗
• MalfunctionJun 5, 2020Material Rupture; Gas/Air Leak; Pressure Problem; Material Rupture; Gas/Air Leak; Pressure Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2020-00083 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00085 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00086 FOR THE FOURTH REPORT. IT WAS REPORTED THAT "SEVERAL" INCIDENTS OF SUBGLOTTIC ET [ENDOTRACHEAL] TUBE CUFF LEAKS OCCURRED THAT ARE NOTICED VIA CUFF PRESSURE CHECKS "ANYWHERE FROM 2-14 DAYS AFTER INTUBATION." ANESTHESIOLOGIST DOES NOT ALWAYS CHECK ETT [ENDOTRACHEAL TUBE] CUFF PATENCY PRIOR TO INTUBATION. ALL TUBES ARE PLACED VIA VIDEO LARYNGOSCOPE TO CONFIRM CORRECT TUBE PLACEMENT. WHEN CUFF LEAKS ARE NOTICED ALL PATIENTS HAVE REQUIRED REINTUBATION WITHOUT DIFFICULTY. PILOT BALLOON ALSO RUPTURED. NO PATIENT INJURIES. PATIENT INFORMATION WAS PROVIDED. DATE INTUBATED: (B)(6) 2020, DATE EXTUBATED: (B)(6) 2020, PEEP SETTINGS: 6-16, NO LOT CODE PROVIDED. ADDITIONAL INFORMATION RECEIVED 22-MAY-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE PROBLEM WAS DISCOVERED THROUGH NORMAL PATIENT MONITORING. THE INCIDENT DID NOT OCCUR DURING SU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10126208 ↗
• MalfunctionJun 5, 2020Material Rupture; Gas/Air Leak; Pressure Problem; Material Rupture; Gas/Air Leak; Pressure Problem

  USER FACILITY REPORT (B)(4) WAS RECEIVED 12-JUN-2020. DESCRIPTION OF EVENT WAS "ETT [ENDOTRACHEAL TUBE] LEAK, REQUIRING EXCHANGE OF TUBE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10126207 ↗