AVANOS 13222Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00609038132228), received between Aug 11, 2020 and Feb 16, 2022 — classified as 2 deaths, 19 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• DeathFeb 16, 2022Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2022-00014 FOR THE SECOND REPORT. ADDITIONAL INFORMATION RECEIVED, 20JAN2022 REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF COVID AND WAS BEING HELD IN THE EMERGENCY DEPARTMENT ON BIPAP TO MAINTAIN OXYGENATION AND OTHER CARE NEEDS. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND DUE TO NO VENTILATORS BEING AVAILABLE AT THE HOSPITAL THE PATIENT WAS TRANSFERRED TO A NEW FACILITY. UPON ARRIVAL AT THE NEW FACILITY THE PATIENT WAS REPORTED TO BE UNCONSCIOUS, HAD SEVERE TACHYCARDIA, TACHYPNEA AND AN OXYGEN LEVEL OF 39%. AFTER AN UNSUCCESSFUL ATTEMPT TO INTUBATE THE PATIENT, DUE TO THE ENDOTRACHEAL (ET) TUBE CUFF NOT INFLATING, THE PATIENT WAS SUCCESSFULLY INTUBATED ON THE THIRD ATTEMPT. ADDITIONALLY, A BAG/MASK [WAS USED] UNTIL A NEW ET TUBE WAS AVAILABLE. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND EXPIRED, THE PATIENT WAS DNR STATUS (DO NOT RESUSCITATE).

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 13546237 ↗
• DeathFeb 16, 2022Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2022-00013 FOR THE FIRST REPORT. ADDITIONAL INFORMATION RECEIVED, (B)(6) 2022 REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF COVID AND WAS BEING HELD IN THE EMERGENCY DEPARTMENT ON BIPAP TO MAINTAIN OXYGENATION AND OTHER CARE NEEDS. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND DUE TO NO VENTILATORS BEING AVAILABLE AT THE HOSPITAL THE PATIENT WAS TRANSFERRED TO A NEW FACILITY. UPON ARRIVAL AT THE NEW FACILITY THE PATIENT WAS REPORTED TO BE UNCONSCIOUS, HAD SEVERE TACHYCARDIA, TACHYPNEA AND AN OXYGEN LEVEL OF 39%. AFTER AN UNSUCCESSFUL ATTEMPT TO INTUBATE THE PATIENT, DUE TO THE ENDOTRACHEAL (ET) TUBE CUFF NOT INFLATING, THE PATIENT WAS SUCCESSFULLY INTUBATED ON THE THIRD ATTEMPT. ADDITIONALLY, A BAG/MASK [WAS USED] UNTIL A NEW ET TUBE WAS AVAILABLE. IT WAS REPORTED THAT THE PATIENT CONTINUED TO DECLINE AND EXPIRED, THE PATIENT WAS DNR STATUS (DO NOT RESUSCITATE).

  Patient problems: Low Oxygen Saturation; Tachycardia

  MAUDE report 13545983 ↗
• MalfunctionJan 27, 2022Decrease in Pressure; Gas/Air Leak; Decrease in Pressure; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO (B)(4)FOR THE FIRST REPORT. IT WAS REPORTED THAT THE CUFF WAS FAULTY DURING INFLATION, DESPITE PRE-TESTING PRIOR TO USE. THE DEVICE WAS CHANGED OUT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369692 ↗
• MalfunctionJan 27, 2022Decrease in Pressure; Gas/Air Leak; Decrease in Pressure; Gas/Air Leak

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO (B)(4) FOR THE SECOND REPORT. IT WAS REPORTED THAT THE CUFF WAS FAULTY DURING INFLATION, DESPITE PRE-TESTING PRIOR TO USE. THE DEVICE WAS CHANGED OUT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13369666 ↗
• MalfunctionJan 17, 2022Gas/Air Leak; Gas/Air Leak

  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 SECOND OF TWO REPORTS. REFER TO 9611594-2022-00003 FOR THE FIRST REPORT. IT WAS REPORTED THAT THERE WAS A LEAKAGE IN THE CUFF MEMBRANE. THE CUFF WAS TESTED PRIOR TO PLACING IN THE PATIENT AND NO ISSUES WERE NOTED. THE DEVICE HAD BEEN IN PLACE FOR TWO HOURS. PER ADDITIONAL INFORMATION RECEIVED 30 DEC 2021 THE PATIENT'S CONDITION AFTER THE INCIDENT WAS "AS FINE AS CAN BE." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267775 ↗
• MalfunctionJan 17, 2022Gas/Air Leak; Gas/Air Leak

  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 9611594-2022-00004 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS A LEAKAGE IN THE CUFF MEMBRANE. THE CUFF WAS TESTED PRIOR TO PLACING IN THE PATIENT AND NO ISSUES WERE NOTED. THE DEVICE HAD BEEN IN PLACE FOR TWO DAYS. PER ADDITIONAL INFORMATION RECEIVED 30 DEC 2021 THE PATIENT'S CONDITION AFTER THE INCIDENT WAS "AS FINE AS CAN BE." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13267770 ↗
• MalfunctionOct 22, 2021Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00153 FOR THE SECOND EVENT. IT WAS REPORTED THE TUBES WAS "MIGRATING HIGH AND GETTING OVER INFLATED WHILE PRONING." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-SEP-2021 STATED, "THERE WERE SOME X-RAYS REVIEWED BY THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETISTS) THAT SHOWED THE TUBE HAD MOVED UP FROM THE CARINA. IT WAS SUGGESTED THAT CUFF INFLATION COULD HAVE BEEN AN ISSUE. THE CUFF PRESSURES WERE NOT CHECKED. THE PATIENT WAS EXTUBATED AND REINTUBATED. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681268 ↗
• MalfunctionOct 22, 2021Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00152 FOR THE FIRST EVENT. IT WAS REPORTED THE TUBES WAS "MIGRATING HIGH AND GETTING OVER INFLATED WHILE PRONING." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-SEP-2021 STATED, "THERE WERE SOME X-RAYS REVIEWED BY THE CRNA (CERTIFIED REGISTERED NURSE ANESTHETISTS) THAT SHOWED THE TUBE HAD MOVED UP FROM THE CARINA. IT WAS SUGGESTED THAT CUFF INFLATION COULD HAVE BEEN AN ISSUE. THE CUFF PRESSURES WERE NOT CHECKED. THE PATIENT WAS EXTUBATED AND REINTUBATED. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681266 ↗
• MalfunctionOct 22, 2021Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2021-00148 FOR THE FIRST EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) CUFF HAD BLOWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681260 ↗
• MalfunctionOct 22, 2021Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2021-00149 FOR THE SECOND EVENT. IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) CUFF HAD BLOWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681259 ↗
• MalfunctionSep 24, 2021Burst Container or Vessel; Burst Container or Vessel

  FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) RECEIVED ON 01-SEP-2021, AND THE FOLLOWING INFORMATION WAS PROVIDED: "PATIENT HAD TO BE REINTUBATED BECAUSE THE PILOT BALLOON OF THE AVANOS MICROCUFF SUBGLOTTIC SUCTIONING ADULT ENDOTRACHEAL TUBE RUPTURE DURING TREATMENT." WHAT WAS THE INTENDED PROCEDURE? "PATIENT WAS MECHANICALLY VENTILATED TO ASSIST WITH MEDICAL CONDITION."

  Patient problems: Unintended Extubation

  MAUDE report 12530356 ↗
• MalfunctionAug 6, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE PATIENT WAS "STATUS EPILEPTICUS SO DECIDED TO I+V [INTUBATE AND VENTILATE]. PREPPED ETT [ENDOTRACHEAL TUBE] SIZE 8.0 TUBE, CUFF CHECKED PRIOR TO INTUBATION AND WAS INFLATING WELL. ONCE INTUBATED, ATTEMPTED TO INFLATE CUFF BUT KEPT ON DEFLATING WITH AUDIBLE CUFF LEAK." PATIENT WAS NOT INJURED, BUT HAD TO BE REINTUBATED AND WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288824 ↗
• MalfunctionJun 3, 2021Disconnection; Gas/Air Leak; Disconnection; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS "REPEATED DISCONNECTION OF THE END OF THE TUBE AND THE CUFF OF THE TUBE IS NOT WATERPROOF (POROUS) WITH WATER INSIDE." ADDITIONAL INFORMATION RECEIVED 19-MAY-2021 INDICATED THE CUFF WAS LOSING AIR WHEN INFLATED. ADDITIONAL INFORMATION RECEIVED 20-MAY-2021 INDICATED THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. REINTUBATION WAS REQUIRED. THE ISSUE WITH THE CUFF WAS NOTICED WHEN "THE CUFF LOST AIR WHEN INFLATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931449 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLUE VENT CONNECTOR WOULD NOT STAY ATTACHED TO THE ENDOTRACHEAL TUBE. THIS WAS NOTED IMMEDIATELY AFTER INTUBATION, WHEN THE VENT ALARM WENT OFF. THE RESPIRATORY THERAPIST UNSUCCESSFULLY TRIED TAPING THE VENT CONNECTOR IN PLACE. THE CONNECTOR HAD TO BE REPLACED WITH A SHILEY VENT CONNECTOR, AND THERE WERE NO FURTHER ISSUES. THERE WAS NO PATIENT DISTRESS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716582 ↗
• MalfunctionDec 5, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THERE WAS AND INCIDENT OF THE CUFF NOT HOLDING AIR. THE CUFF WAS NOT INFLATING ON INTUBATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10954143 ↗
• MalfunctionOct 8, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2020-00194 FOR THE FIRST EVENT. REFER TO 9611594-2020-00196 FOR THE SECOND EVENT. REFER TO 9611594-2020-00197 FOR THE THIRD EVENT. IT WAS REPORTED THE CLINICIANS EXPERIENCED A CUFF FAILURE ON THE SUBGLOTTIC MICROCUFF ENDOTRACHEAL TUBE. "PER THE FACILITY, THE CUFF WAS TESTED PRIOR TO INTUBATION AND SUCCESSFULLY HELD AIR/PRESSURE. ONCE INTUBATED, THE CUFF WOULDN'T INFLATE." THE PATIENT WAS EXTUBATED ULTIMATELY REINTUBATED WITH ANOTHER ENDOTRACHEAL TUBE (ETT) AND THE CUFF INFLATED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 10648684 ↗
• MalfunctionOct 8, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2020-00194 FOR THE FIRST EVENT. REFER TO 9611594-2020-00196 FOR THE SECOND EVENT. REFER TO 9611594-2020-00198 FOR THE FOURTH EVENT. IT WAS REPORTED THE CLINICIANS EXPERIENCED A CUFF FAILURE ON THE SUBGLOTTIC MICRO CUFF ENDOTRACHEAL TUBE. "PER THE FACILITY, THE CUFF WAS TESTED PRIOR TO INTUBATION AND SUCCESSFULLY HELD AIR/PRESSURE. ONCE INTUBATED, THE CUFF WOULDN'T INFLATE." THE PATIENT WAS EXTUBATED ULTIMATELY REINTUBATED WITH ANOTHER ENDOTRACHEAL TUBE (ETT) AND THE CUFF INFLATED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 10648678 ↗
• MalfunctionOct 8, 2020Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2020-00194 FOR THE FIRST EVENT. REFER TO 9611594-2020-00197 FOR THE THIRD EVENT. REFER TO 9611594-2020-00198 FOR THE FOURTH EVENT. IT WAS REPORTED THE CLINICIANS EXPERIENCED A CUFF FAILURE ON THE SUBGLOTTIC MICROCUFF ENDOTRACHEAL TUBE. "PER THE FACILITY, THE CUFF WAS TESTED PRIOR TO INTUBATION AND SUCCESSFULLY HELD AIR/PRESSURE. ONCE INTUBATED, THE CUFF WOULDN'T INFLATE." THE PATIENT WAS EXTUBATED ULTIMATELY REINTUBATED WITH ANOTHER ENDOTRACHEAL TUBE (ETT) AND THE CUFF INFLATED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 10648676 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL INC. 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 9611594-2020-00149 FOR THE FIRST REPORT. REFER TO 9611594-2020-00150 FOR THE SECOND REPORT. IT WAS REPORTED THAT "THE CUFF BROKE WHILE BLOCKING/PUMPING IT UP." THERE WAS NO REPORTED INJURY. NO FURTHER INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED 07-AUG-2020, THE CUFF BROKE DURING VENTILATION. THE DEVICE HAD PREVIOUSLY BEEN INTACT. THE PATIENT WAS RE-INTUBATED, AND WAS INADEQUATELY VENTILATED FOR A SHORT PERIOD, BUT THIS DID NOT LEAD TO ANY CHANGE IN PATIENT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391219 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL INC. 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 9611594-2020-00149 FOR THE FIRST REPORT. REFER TO 9611594-2020-00151 FOR THE THIRD REPORT. IT WAS REPORTED THAT "THE CUFF BROKE WHILE BLOCKING/PUMPING IT UP." THERE WAS NO REPORTED INJURY. NO FURTHER INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED 10-AUG-2020, THE CUFF BROKE DURING VENTILATION. THE DEVICE HAD PREVIOUSLY BEEN INTACT. THE PATIENT WAS RE-INTUBATED, AND WAS INADEQUATELY VENTILATED FOR A SHORT PERIOD, BUT THIS DID NOT LEAD TO ANY CHANGE IN PATIENT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391207 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  AVANOS MEDICAL INC. 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 9611594-2020-00150 FOR THE SECOND REPORT. REFER TO 9611594-2020-00151 FOR THE THIRD REPORT. IT WAS REPORTED THAT "THE CUFF BROKE WHILE BLOCKING/PUMPING IT UP." THERE WAS NO REPORTED INJURY. NO FURTHER INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED 07-AUG-2020, THE CUFF BROKE DURING VENTILATION. THE DEVICE HAD PREVIOUSLY BEEN INTACT. THE PATIENT WAS RE-INTUBATED, AND WAS INADEQUATELY VENTILATED FOR A SHORT PERIOD, BUT THIS DID NOT LEAD TO ANY CHANGE IN PATIENT CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391190 ↗