AVANOS 35113Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00609038351131), received between Aug 31, 2022 and Jul 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011355 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED, THE TUBE CONNECTING THE CUFF AND THE BALLOON BROKE THE DAY AFTER INTUBATION. [THE] PATIENT [WAS REPORTED TO BE] STABLE, VENTILATION [WAS] NOT AFFECTED. [THE] PATIENT [WAS] EXTUBATED ON [THE] SAME DAY. ENDOTRACHEAL [ETT] TUBE INTACT. NO RETAINED MATERIAL. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877918 ↗
• MalfunctionDec 12, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A HOLE IN THE CUFF WAS DISCOVERED DURING PATIENT USE. THERE WAS NO DELAY IN THERAPY, NOR ANY HARM OR INJURY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23793094 ↗
• MalfunctionJun 4, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED, THE PATIENT WAS INTUBATED WITH THE MICROCUFF 4.0 TUBE; HOWEVER, THE STAFF WERE NOT ABLE TO SUCTION THEM PROPERLY WHICH RESULTED IN A DELAY IN CARE. A WORK AROUND WAS DEVELOPED, USING A DIFFERENT ENDOTRACHEAL TUBE (ETT) HUB ADAPTER. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11APR2025 REPORTED, DUE TO A BACKORDER WITH THEIR NORMAL ENDOTRACHEAL TUBE, THE STAFF USED THE Y-STYLE NEO/PEDIATRIC SUCTION ELBOW STYLE CATHETERS WITH THE MICROCUFF AND NOTICED THE CATHETER COULD NOT ADVANCE PAST THE ADAPTER THAT CONNECTS IT TO THE SUCTION CATHETER. THE WALLS ON THE ADAPTER SEEMED 'THICKER' AND THE CATHETER FREQUENTLY HUNG-UP AND KINKED WHEN THE CLINICIANS TRIED TO ADVANCE IT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146898 ↗
• MalfunctionFeb 14, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED, THE CUFF 'BLEW UP' ON TWO PARTS OF THE MICROCUFF; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21387174 ↗
• MalfunctionSep 11, 2024Decrease in Pressure; Gas/Air Leak; Unintended Deflation; Decrease in Pressure; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED, AT APPROXIMATELY 06:45 AM, THE PATIENT WAS NOTED TO HAVE AN AUDIBLE LEAK AND THEIR SATURATIONS STARTED TO DROP FROM BASELINE (20 MMHG), THE CUFF MANOMETER MARKED INADEQUATE PRESSURE AND THE CUFF WAS DEFLATED. SEVERAL ATTEMPTS WERE MADE TO REINFLATE THE; HOWEVER, WITHIN 5 MINS (OF BEING REINFLATED) THE CUFF WOULD SLIGHTLY DEFLATE. THE PATIENT WAS REINTUBATED; THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20192534 ↗
• MalfunctionJul 29, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, "THE CUFF FAILED; THE BULB DID NOT WORK PROPERLY"; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 08JUL2024 REPORTED, THE PATIENT ARRIVED FROM THE EMERGENCY DEPARTMENT (ED) WITH A BLOWN CUFF IN THE ENDOTRACHEAL TUBE (ETT). [THE] PATIENT WAS INTUBATED IN THE EMERGENCY ROOM (ER) WITH A 4.0. ED RESPIRATORY THERAPIST (RT) STATED VOLUME LOSS ON THE VENTILATOR, BUT IT WAS DUE TO THE BLOWN ETT PILOT BALLOON. PATIENT WAS REINTUBATED ON "H2B"; THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19852685 ↗
• MalfunctionMay 7, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON (B)(6) 2024, THE MICROCUFF TRACHEAL TUBE (ETT) WAS CHECKED FOR LEAKS DURING USE AND A LEAK OCCURRED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19264527 ↗
• MalfunctionJun 19, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE MICROCUFF VENT CONNECTOR DETACHED DURING USE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17151251 ↗
• MalfunctionAug 31, 2022Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2022-00063 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00065 FOR THE THIRD EVENT. IT WAS REPORTED THE "PAEDIATRIC MICROCUFF CUFF [WAS] LOSING VOLUME AND ON REMOVAL" THE CUFF WAS SEEN TO BE SPLIT. THE PATIENT REQUIRED REINTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328860 ↗
• MalfunctionAug 31, 2022Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2022-00064 FOR THE SECOND EVENT. REFER TO 3011270181-2022-00065 FOR THE THIRD EVENT. IT WAS REPORTED THE "PAEDIATRIC MICROCUFF CUFF [WAS] LOSING VOLUME AND ON REMOVAL" THE CUFF WAS SEEN TO BE SPLIT. THE PATIENT REQUIRED REINTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328854 ↗
• MalfunctionAug 31, 2022Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2022-00063 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00064 FOR THE SECOND EVENT. IT WAS REPORTED THE "PAEDIATRIC MICROCUFF CUFF [WAS] LOSING VOLUME AND ON REMOVAL" THE CUFF WAS SEEN TO BE SPLIT. THE PATIENT REQUIRED REINTUBATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328841 ↗