AVANOS 35112Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00609038351124), received between Aug 18, 2021 and Aug 14, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED; THE RESPIRATORY THERAPIST (RT) FOUND THE PILOT LINE UNATTACHED (DURING A ROUTINE REMOVAL/RE-TAPE OF THE ENDOTRACHEAL TUBE (ETT) TAPE(S) THEY FOUND THE ETT ALREADY DETACHED). THE PATIENT'S ETT WAS LEFT IN-SITU UNTIL TAKEN TO THE OPERATING ROOM ON (B)(6) 2025 FOR AN ETT EXCHANGED. IT WAS ADDITIONALLY REPORTED, DURING THE EVENT, THE PATIENT WAS ABLE TO BE VENTILATED WITH [THE] CUFF DOWN. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811471 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE RESPIRATORY THERAPIST (RT) FOUND THE PILOT LINE UNATTACHED (DURING A ROUTINE REMOVAL/RE-TAPE OF THE ENDOTRACHEAL TUBE (ETT) TAPE(S) THEY FOUND THE ETT ALREADY DETACHED). THE PATIENT'S ETT WAS LEFT IN-SITU UNTIL TAKEN TO THE OPERATING ROOM ON (B)(6) 2025 FOR AN ETT EXCHANGED. IT WAS ADDITIONALLY REPORTED, DURING THE EVENT, THE PATIENT WAS ABLE TO BE VENTILATED WITH [THE] CUFF DOWN. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808838 ↗
• InjuryJun 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, CALLED INTO PATIENT'S ROOM DUE TO REGISTERED NURSE (RN) BAGGING PATIENT. RN MENTIONED A LEAK IN THE ENDOTRACHEAL TUBE (ETT), RESPIRATORY THERAPIST (RT) CHECKED TUBE PLACEMENT, AND IT WAS A LITTLE HIGH WHERE IT WAS SUPPOSED TO BE PLACED. BOTH RT AND OTHER RT RETAPED THE TUBE TO THE CORRECT POSITION WHICH WAS 9 AT THE GUM AND A CHEST XRAY (CXR) WAS TAKEN FOR TUBE PLACEMENT. UPON X-RAY THE TUBE WAS HIGH AND CONFIRMED BY ADVANCED PRACTICE NURSE (APN). THE TUBE WAS THEN PUSHED IN TO 10 AND ANOTHER X-RAY WAS TAKEN. UPON X-RAY THE TUBE WAS STILL HIGH WHICH WAS CONFIRMED BY APN AND SO THE TUBE WAS ONCE AGAIN PUSHED TO 11. THE X-RAY STILL SHOWED IT WAS HIGH. THE PATIENT'S SATURATIONS WERE LOWER, SO THE ATTENDING MEDICAL DOCTOR (MD) AND OTHER APN WAS CALLED TO THE ROOM TO REVIEW X-RAYS AS WELL. MD ASKED FOR THE CLINICAL MEDICAL ASSISTANT CERTIFIED (CMAC) TO USE TO OBSERVE WHAT WAS GOING ON WITH THE ETT INSIDE THE PATIENT'S MOUTH. ONCE THE BLADE WAS IN USE, THE CAMERA SHOWED THE ETT WAS THROUGH THE VOCAL CORDS SHOWING THE ETT WAS STILL IN PLACE, BUT DUE TO THE PATIENT DESATSURATIONS AND BRADY, THE DECISION WAS MADE TO SWITCH OUT THE TUBES JUST IN CASE THERE WAS SOMETHING DEFE

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 22155518 ↗
• InjuryMay 7, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, DURING SUCTIONING OF THE PATIENT (AFTER TRANSPLANTATION), THE PATIENT¿S BODY MOVEMENT INTENSIFIED, AND THE CUFF WAS TORN OFF FROM THE BASE OF THE TUBE. IT WAS ADDITIONALLY REPORTED, EVERY DAY THE BODY MOVEMENT WAS SEVERE, AND HE WAS ANALGESIC WITH PAIN KILLERS, BUT HE WAS MOVING DURING SUCTION. THE PATIENT WAS INTUBATED, ¿THE PERIOD WAS PROLONGED¿, AND THE TUBE WAS FIXED WITH A NEOBAR. A TRACHEAL TUBE OF THE SAME SIZE WAS REPLACED; THERE WAS NO REPORTED INJURY TO THE PATIENT. THE EVENT REPORTEDLY OCCURRED AROUND 10:30AM.

  Patient problems: Insufficient Information

  MAUDE report 19258558 ↗
• InjuryApr 8, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PATIENT EXPERIENCED ACUTE DESATURATION DURING A DIAPER CHANGE; THE EVENT RESOLVED WITH 'PRO RE NATA,' (PRN) SEDATION AND FRACTION OF INSPIRED OXYGEN (FIO2) BOOST. DURING RESUSCITATION, THE RESPIRATORY THERAPISTS (RT) NOTED THE ENDOTRACHEAL (ETT)CUFF PILOT LINE (BALLOON) BECAME DISCONNECTED FROM THE ETT. IT WAS ADDITIONALLY REPORTED, THE PATIENT, WHO WAS ON A PROLONGED INTUBATION COURSE, BECAME VERY AGITATED WITH THE "CARES", (DURING A MORNING DIAPER CHANGE), AND PROGRESSIVELY DESATURATED TO A NADIR OF 9% WITHOUT BRADYCARDIA OR LOSS OF CONSCIOUSNESS AND WITH CYANOSIS, WHICH QUICKLY IMPROVED TO THE 50'S% WITH COMFORT MEASURES AND INCREASED FIO2. [THE] PATIENT RECEIVED MORPHINE AND MIDAZOLAM WHICH SETTLED HIM, AND SATURATIONS RESOLVED TO THE LOW 80S (HIS NORMAL BASELINE). THE RT PERFORMED A LAMBROS'S ASSESSMENT; THE PATIENT REPORTEDLY HAD AUDIBLE BREATH SOUNDS BILATERALLY. THE PRESSURE WAS CHECKED ON THE CUFF OF THE (ETT) AND IT WAS NOTED THE BALLOON ON THE PILOT LINE WAS INFLATED BUT DID NOT APPEAR TO EXPEL AIR AND DEFLATE[D] WHEN SQUEEZED. [DURING THE ASSESSMENT], THE ETT IMMEDIATELY PULLED OUT OF THE PATIENT'S MOUTH. IT WAS REPORTED, THE LINE HAD POTENTIALLY SH

  Patient problems: Low Oxygen Saturation; Unspecified Respiratory Problem

  MAUDE report 19066584 ↗
• MalfunctionJun 20, 2023Separation Problem; Separation Problem

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

  Patient problems: Insufficient Information

  MAUDE report 17165363 ↗
• MalfunctionSep 28, 2022Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED 10-NOV-2022 STATED "AS THE BATCH HAS BEEN CONFIRMED AS THE SAME BATCH AS THE END-USER REPORTED. IN ADDITION, THE END-USER REPORTED ON THE 01-SEP-2022 'THE CONSULTANT CHANGED THE ETT TUBE AGAIN TODAY DUE TO THE CUFF LEAKING AGAIN OVERNIGHT."

  Patient problems: Low Oxygen Saturation

  MAUDE report 15499017 ↗
• MalfunctionSep 28, 2022Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL 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 3011270181-2022-00072 FOR THE FIRST EVENT. REFER TO 3011270181-2022-00073 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE (ETT) CUFF DEFLATED DURING USE. THE ETT TUBE WAS REPLACED WITH A NEW TUBE. NO FURTHER MEDICAL INTERVENTIONS REPORTED

  Patient problems: Insufficient Information

  MAUDE report 15498982 ↗
• MalfunctionSep 28, 2022Gas/Air Leak; Gas/Air Leak

  ADDITIONAL INFORMATION RECEIVED 10-NOV-2022 STATED "AS THE BATCH HAS BEEN CONFIRMED AS THE SAME BATCH AS THE END-USER REPORTED. IN ADDITION, THE END-USER REPORTED ON THE 01-SEP-2022 'THE CONSULTANT CHANGED THE ETT TUBE AGAIN TODAY DUE TO THE CUFF LEAKING AGAIN OVERNIGHT."

  Patient problems: Low Oxygen Saturation

  MAUDE report 15498896 ↗
• MalfunctionFeb 10, 2022Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON INFLATION TUBING DISCONNECTED FROM THE INTUBATION TUBE, RESULTING IN CUFF DEFLATION. THE TUBE WAS PLACED ON (B)(6) 2022 AND DURING RE-INFLATION ON (B)(6) 2022 THE NURSE NOTED THAT THE CUFF WAS NOT REINFLATING. PER ADDITIONAL INFORMATION RECEIVED 27 JAN 2022, THERE WERE NO NEGATIVE CONSEQUENCES TO THE PATIENT. THE DEVICE HAD BEEN IN USE FOR 72 HOURS. PER ADDITIONAL INFORMATION RECEIVED 31 JAN 2022, THE TUBE WITH DEFLATED CUFF WAS LEFT IN THE PATIENT, DESCRIBED AS COMMON PRACTICE IN PEDIATRICS. CARE OF THE PATIENT WAS CONTINUED WITHOUT ANY FURTHER PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508266 ↗
• InjuryNov 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AN INTUBATED INFANT WAS DESATURATING AND NOT ACHIEVING SET TIDAL VOLUMES. IT WAS DISCOVERED THAT THE BLUE CONNECTOR ON THE END OF THE ENDOTRACHEAL TUBE (ETT) KEPT FALLING OFF AND WAS DIFFICULT TO KEEP ATTACHED TO THE TUBE. THE TUBE WAS ALSO KINKED. THE STAFF REPORTED "DIFFICULTY WITH MANAGEMENT OF AIRWAY AND BREATHING WITH MULTIPLE DISCONNECTIONS WHEN TRYING TO CHANGE FROM VENTILATOR TO AMBUBAG AND BACK AGAIN." THE PATIENT WAS EXTUBATED THE NEXT DAY AND IS AN INPATIENT AT (B)(6) HOSPITAL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 12851488 ↗
• MalfunctionAug 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PER ADDITIONAL INFORMATION RECEIVED 1 SEP 2021, IT WAS THE VENT CONNECTOR THAT HAD DETACHED, NOT THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367133 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3011270181-2021-00048 FOR THE FIRST REPORT. REFER TO 3011270181-2021-00039 FOR THE SECOND REPORT. REFER TO 3011270181-2021-00040 FOR THE THIRD REPORT. REFER TO 3011270181-2021-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE BLUE CONNECTOR CAME AWAY FROM THE MICROCUFF ET TUBE (ETT). NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335636 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3011270181-2021-00038 FOR THE FIRST REPORT. REFER TO 3011270181-2021-00039 FOR THE SECOND REPORT . REFER TO 3011270181-2021-00040 FOR THE THIRD REPORT . REFER TO 3011270181-2021-00041 FOR THE FOURTH REPORT . IT WAS REPORTED THAT THE BLUE CONNECTOR CAME AWAY FROM THE MICROCUFF ET TUBE (ETT). NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335634 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3011270181-2021-00038 FOR THE FIRST REPORT. REFER TO 3011270181-2021-00040 FOR THE THIRD REPORT. REFER TO 3011270181-2021-00041 FOR THE FOURTH REPORT. REFER TO 3011270181-2021-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE BLUE CONNECTOR CAME AWAY FROM THE MICROCUFF ET TUBE (ETT). NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335633 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 3011270181-2021-00048 FOR THE FIRST REPORT. REFER TO 3011270181-2021-00039 FOR THE SECOND REPORT. REFER TO 3011270181-2021-00041 FOR THE FOURTH REPORT. REFER TO 3011270181-2021-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE BLUE CONNECTOR CAME AWAY FROM THE MICROCUFF ET TUBE (ETT). NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335630 ↗
• MalfunctionAug 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 3011270181-2021-00039 FOR THE SECOND REPORT. REFER TO 3011270181-2021-00040 FOR THE THIRD REPORT. REFER TO 3011270181-2021-00041 FOR THE FOURTH REPORT. REFER TO 3011270181-2021-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE BLUE CONNECTOR CAME AWAY FROM THE MICROCUFF ET TUBE (ETT). NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335626 ↗