AVANOS 35115Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00609038351155), received between Jul 22, 2020 and Jul 27, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 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 50011352 ↗
• MalfunctionFeb 12, 2026Complete Blockage

  IT WAS REPORTED, THE 5.0 ENDOTRACHEAL TUBE (ETT) SEMED TO BE KINKED IN THE PATIENT'S OROPHARYNX PREVENTING THE SUCTION CATHETER FROM PASSING. A MINIMAL [UNSPECIFIED] HARM WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 24326062 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2026-00001 FOR THE FIRST REPORT. REFER TO 3011270181-2026-00002 FOR THE SECOND REPORT. IT WAS REPORTED, THE TUBE TWISTED AFTER INSERTION AND OCCLUDED THE PATIENT'S AIRWAY WHICH PREVENTED THE SUCTION CATHETER FROM BEING PASSED; THE CATHETER WAS REPLACED. THE EVENT RESULTED IN THE ACUTE DETERIORATION OF THE PATIENT; NO ADDITIONAL INFORMATION PROVIDED CONCERNING THE PATIENT'S OUTCOME.

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

  MAUDE report 24101716 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2026-00001 FOR THE FIRST REPORT. REFER TO 3011270181-2026-00003 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE TWISTED AFTER INSERTION AND OCCLUDED THE PATIENT'S AIRWAY WHICH PREVENTED THE SUCTION CATHETER FROM BEING PASSED; THE CATHETER WAS REPLACED. THERE WAS NO REPORTED INJURY.

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

  MAUDE report 24101708 ↗
• MalfunctionJan 16, 2026Material Twisted/Bent

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2026-00002 FOR THE SECOND REPORT. REFER TO 3011270181-2026-00003 FOR THE THIRD REPORT. IT WAS REPORTED, THE TUBE TWISTED AFTER INSERTION AND OCCLUDED THE AIRWAY WHICH PREVENTED THE SUCTION CATHETER FROM BEING PASSED; THE CATHETER WAS REPLACED. THERE WAS NO REPORTED INJURY.

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

  MAUDE report 24101310 ↗
• MalfunctionJan 1, 2026Material Twisted/Bent

  IT WAS REPORTED, THE TUBE WAS KINKED WHILE IN USE; THE TUBE WAS CHANGED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23939776 ↗
• MalfunctionMar 14, 2025Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  RESPIRATORY CONTROL WAS FINE PRIOR AND DURING SURGERY. AFTER RETURNING TO THE ROOM, THE PATIENT'S VENTILATION RATE DID NOT INCREASE, AND ALTHOUGH BAG VENTILATION WAS PERFORMED MANUALLY,THE AIRFLOW WAS NOT GOING WELL. THEREFORE EXTUBATED THE PATIENT. THE MICRO CUFF WAS FOUND TO BE KINKED AT 8 CM FROM THE TIP. THIS WAS THE FIRST TIME THIS HAD HAPPENED, AS THE MICRO CUFF USUALLY DOES NOT REMAIN BENT DURING INTRAOPERATIVE X-RAYS. AT THE TIME OF RECOVERY OF THE PRODUCT IN QUESTION, THE MARK OF THE BENT PORTION COULD NOT BE CONFIRMED BY THE NAKED EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612809 ↗
• MalfunctionNov 19, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED, THE PATIENT WAS INTUBATED IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU) AND AFTER A WHILE THE AIR LEAKED OUT OF THE CUFF; AN ATTEMPT WAS MADE TO REINFLATE THE CUFF; HOWEVER, IT DEFLATED AGAIN. THE CUFF WAS REPLACED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728356 ↗
• MalfunctionMay 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE PATIENT WAS INTUBATED ON DAY SHIFT AND SHOWED SIGNS OF A KINKED TUBE BY THE NIGHT SHIFT STAFF; THE PATIENT WAS REINTUBATED, THERE WAS NO KNOWN HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261137 ↗
• MalfunctionApr 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THERE IS A DISCONNECTION BETWEEN THE ET TUBE AND THE CONNECTOR, (THE CONNECTOR CAME APART); THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 25MAR2024 REPORTED, A PATIENT WAS ¿AFFECTED¿ (UNSPECIFIED), NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121940 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 3011270181-2023-00106 FOR THE SECOND REPORT . REFER TO 3011270181-2023-00107 FOR THE THIRD REPORT . IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF LOSES AIR PRESSURE AND HAS TO BE REINFLATED. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17261200 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 3011270181-2023-00102 FOR THE FIRST REPORT REFER TO 3011270181-2023-00107 FOR THE THIRD REPORT IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF LOSES AIR PRESSURE AND HAS TO BE REINFLATED. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17260724 ↗
• MalfunctionJul 5, 2023Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 3011270181-2023-00102 FOR THE FIRST REPORT. REFER TO 3011270181-2023-00106 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF LOSES AIR PRESSURE AND HAS TO BE REINFLATED. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17259635 ↗
• MalfunctionJun 30, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE MICROCUFF ENDOTRACHEAL TUBE (ETT) HAD CUFF HAD AN EXPIRATORY LEAK. THE BALLOON WOULD NOT STAY INFLATED. THE ETT WAS REMOVED AND REPLACED WITH A NEW TUBE. NO FURTHER ISSUES OCCURRED. NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 26JUN2023, THE PRODUCT WAS NOT ALTERED. THE ROUTINE PRACTICE AT THE HOSPITAL IS TO NOT INFLATE THE CUFF BEYOND 20MM HG.

  Patient problems: Insufficient Information

  MAUDE report 17238923 ↗
• MalfunctionJun 19, 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 17151412 ↗
• MalfunctionSep 30, 2022Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  IT WAS REPORTED, THE PATIENT WAS REINTUBATED; THE TUBE HAD BEEN IN PLACE FOR 5 HOURS AND KINKED FOLLOWING INTUBATION, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15512725 ↗
• MalfunctionJul 8, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE (ENT) MICROCUFF CUFF, 5.0 MM - KINKED INTRA-ORALLY CAUSING POOR/IMPOSSIBLE VENTILATION; THE ETT WAS REMOVED AND DISPOSED OF. VENTILATION WAS RE-ESTABLISHED WITH A DIFFERENT ENT; THERE WAS NO REPORTED INJURY

  Patient problems: Hypoventilation

  MAUDE report 14961034 ↗
• MalfunctionMay 31, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON A MICROCUFF ENDOTRACHEAL TUBE (ETT) KINKED WHILST A PATIENT WAS IN THE PRONE POSITION, WITH HEAVY NECK FLEXION (CHIN TOWARDS CHEST). THE PATIENT WAS REMOVED FROM THE OPERATING TABLE SO THE ENDOTRACHEAL TUBE COULD BE REPLACED. THE PATIENT WAS REINTUBATED WITH A NEW DEVICE BECAUSE THE CLINICIANS WERE UNABLE TO VENTILATE THE PATIENTS SUCCESSFULLY/EFFICIENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14555552 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MICROCUFF ENDOTRACHEAL TUBE ADAPTER BEING LOOSE AND DISCONNECTING. THE DISCONNECTION OF THE ADAPTER ALLEGEDLY KEPT OCCURRING DURING ROUTING MOVEMENT OF THE VENTILATOR CIRCUIT. THERE WAS NO INJURY TO THE PATIENT. PER INFORMATION RECEIVED 3 AUG 2021, THE PATIENT INVOLVED IS A CHILD, BUT NO FURTHER PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316042 ↗
• MalfunctionAug 11, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  PER DISCUSSION WITH THE PHYSICIAN ON (B)(6) 2020, THE HOSPITAL HAS BEEN USING PEDIATRIC TUBES ON YOUNG ADULT PATIENTS. THEY CONFIRM THAT USING THE PEDIATRIC TUBES ON "WELL-DEVELOPED" TRACHEAE OF YOUNG ADULTS, AND THE HEATING BLANKETS USED ON PATIENTS DURING LONGER SURGERIES AND MRIS, CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393240 ↗
• MalfunctionAug 11, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2020-00109 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS AN INCIDENCE OF TUBE KINKING IN A PATIENT. PER ADDITIONAL INFORMATION RECEIVED 29 JULY 2020, THE PHYSICIAN REPORTED THAT THEY DO NOT USE A HEAT COIL, BUT THEY DO PREFER USING A LOT OF HEAT ON PATIENTS DURING LONGER SURGERIES, AND REQUIRE THAT MRIS ARE MUCH WARMER. NO FURTHER INFORMATION PROVIDED AT THIS TIME, HOWEVER, A REPRESENTATIVE HAS BEEN IN CONTACT WITH THE PHYSICIAN TO PROVIDE TRAINING AND OPTIONS FOR HEATING THE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393190 ↗
• MalfunctionJul 22, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  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 3011270181-2020-00098 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00099 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00100 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00101 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THERE WERE PROBLEMS WITH THE TUBE, AND UPON EXTUBATION, A KINK IN THE TUBE WAS NOTED. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10310640 ↗
• MalfunctionJul 22, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  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 3011270181-2020-00098 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00099 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00100 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00102 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THERE WERE PROBLEMS WITH THE TUBE, AND UPON EXTUBATION, A KINK IN THE TUBE WAS NOTED. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10310592 ↗
• MalfunctionJul 22, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  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 3011270181-2020-00098 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00100 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00101 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00102 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THERE WERE PROBLEMS WITH THE TUBE, AND UPON EXTUBATION, A KINK IN THE TUBE WAS NOTED. NO FURTHER INFORMATION ABOUT THIS EVENT WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10310590 ↗
• MalfunctionJul 22, 2020Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent

  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 3011270181-2020-00099 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00100 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00101 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00102 FOR THE FIFTH REPORT. IT WAS REPORTED THAT AFTER TWO HOURS OF ANESTHESIA DURING MRI-EXAM, A BRONCHIAL OBSTRUCTION OCCURRED. THERE WAS HIGH AIRWAY PRESSURE, HYPERCAPNIA, LOW RESPIRATION, AND TIDAL VOLUME, HOWEVER OXYGEN SATURATION WAS NOT AFFECTED. INITIALLY, ANTI-OBSTRUCTIVE DRUG THERAPY WAS ATTEMPTED, AND ALSO MUCOSUCTION THROUGH THE TUBE AFTER THE MRI WAS COMPLETED. MUCOSUCTION WAS NOT POSSIBLE, HOWEVER, DUE TO A PHARYNGEAL STOP AT 7/8CM FROM THE TIP OF THE TUBE. AFTER EXTUBATION, THE STOP WAS ALLEGEDLY CAUSED BY A KINK NOTED IN THE TUBE. PER ADDITIONAL INFORMATION RECEIVED 6 JUL 2020, PATIENT HAS MUSCULAR DYSTROPHIA AS A PRIOR CONDITION. THE ANTIOBSTRUCTIVE MEDICATION PROVIDED TO THE PATIENT WAS REPROTEROL IV AND INHALATION OF EPINEPHRINE. PATIENT'S CURRENT STATUS IS REPORTED AS "AS BEFORE, RE

  Patient problems: Decreased Respiratory Rate; No Code Available

  MAUDE report 10310558 ↗