AVANOS 35117Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00609038351179), received between May 14, 2022 and Oct 16, 2024 — classified as 2 deaths, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE FIRST OF SIX REPORTS. REFER TO 3011270181-2024-00101 FOR THE FIRST REPORT REFER TO 3011270181-2024-00102 FOR THE SECOND REPORT REFER TO 3011270181-2024-00103 FOR THE THIRD REPORT REFER TO 3011270181-2024-00104 FOR THE FOURTH REPORT REFER TO 3011270181-2024-00105 FOR THE FIFTH REPORT. IT WAS REPORTED, THE STAFF/PHYSICIANS EXPERIENCED KINKS AT THE INSERTION OF THE PILOT LINE WHICH HAS CAUSED DIFFICULTY IN MAINTAINING THE PATIENT'S AIRWAY AND IN SUCTIONING OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 18SEP2024 REPORTED, THE PATIENT WAS INTUBATED OVERNIGHT FOR WORSENING HYPOXIA IN THE SETTING OF PNEUMONIA, WAS PREVIOUSLY ON BIPAP. IN THE MORNING, RESPIRATORY (RT) CHANGED IN-LINE SUCTIONED BALLARD CHANGED TO APPROPRIATE BALLARD. NOTED TO BE UNABLE TO PASS CATHETER. TEMPORARILY ABLE TO SUCTION PATIENT, WITH HIS HEAD HYPEREXTENDED. HOWEVER, QUICKLY DEVELOPED CHANGES IN HEART RATE (HR) WITH DESATURATIONS, AND DECISION MADE TO EXCHANGE ENDOTRACHEAL TUBE (ETT). PATIENT HAD 6.0 MICRO CUFFED ETT IN PLACE¿ [THE] ETT [W

  Patient problems: High Oxygen Saturation; Unspecified Heart Problem

  MAUDE report 20461381 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  THIS IS THE FIFTH OF SIX REPORTS. REFER TO 3011270181-2024-00106 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00101 FOR THE SECOND REPORT. REFER TO 3011270181-2024-00102 FOR THE THIRD REPORT. REFER TO 3011270181-2024-00103 FOR THE FOURTH REPORT. REFER TO 3011270181-2024-00105 FOR THE SIXTH REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20461342 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE THIRD OF SIX REPORTS. REFER TO 3011270181-2024-00100 FOR THE FIRST REPORT REFER TO 3011270181-2024-00101 FOR THE SECOND REPORT REFER TO 3011270181-2024-00103 FOR THE FOURTH REPORT REFER TO 3011270181-2024-00104 FOR THE FIFTH REPORT REFER TO 3011270181-2024-00105 FOR THE SIXTH REPORT IT WAS REPORTED, THE STAFF/PHYSICIANS EXPERIENCED KINKS AT THE INSERTION OF THE PILOT LINE WHICH HAS CAUSED DIFFICULTY IN MAINTAINING THE PATIENT'S AIRWAY AND IN SUCTIONING OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20SEP2024 REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE PATIENT REQUIRED REINTUBATION; THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20461336 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE THIRD OF SIX REPORTS. REFER TO 3011270181-2024-00101 FOR THE FIRST REPORT; REFER TO 3011270181-2024-00102 FOR THE SECOND REPORT; REFER TO 3011270181-2024-00104 FOR THE FOURTH REPORT; REFER TO 3011270181-2024-00105 FOR THE FIFTH REPORT; REFER TO 3011270181-2024-00106 FOR THE SIXTH REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20461298 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE SECOND OF SIX REPORTS. REFER TO 3011270181-2024-00100 FOR THE FIRST REPORT REFER TO 3011270181-2024-00102 FOR THE THIRD REPORT REFER TO 3011270181-2024-00103 FOR THE FOURTH REPORT REFER TO 3011270181-2024-00104 FOR THE FIFTH REPORT REFER TO 3011270181-2024-00105 FOR THE SIXTH REPORT IT WAS REPORTED, THE STAFF/PHYSICIANS EXPERIENCED KINKS AT THE INSERTION OF THE PILOT LINE WHICH HAS CAUSED DIFFICULTY IN MAINTAINING THE PATIENT'S AIRWAY AND IN SUCTIONING OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20SEP2024 REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE PATIENT REQUIRED REINTUBATION; THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20461273 ↗
• MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT PATIENTS. THIS IS THE SIXTH OF SIX REPORTS. REFER TO 3011270181-2024-00100 FOR THE FIRST REPORT. REFER TO 3011270181-2024-00101 FOR THE SECOND REPORT. REFER TO 3011270181-2024-00102 FOR THE THIRD REPORT. REFER TO 3011270181-2024-00103 FOR THE FOURTH REPORT. REFER TO 3011270181-2024-00104 FOR THE FIFTH REPORT. IT WAS REPORTED, THE STAFF/PHYSICIANS EXPERIENCED KINKS AT THE INSERTION OF THE PILOT LINE WHICH HAS CAUSED DIFFICULTY IN MAINTAINING THE PATIENT'S AIRWAY AND IN SUCTIONING OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20SEP2024 REPORTED, THE ENDOTRACHEAL TUBE (ETT) KINKED AND THE PATIENT REQUIRED REINTUBATION; THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20461271 ↗
• InjuryJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) WAS INSERTED FOR EMERGENCY SURGERY ON THE PATIENT WHO WAS A KNOWN ASTHMATIC AND WHO WAS SUSPECTED OF HAVING TESTICULAR TORSION. THE INTUBATION WAS REPORTEDLY "STRAIGHTFORWARD". FIVE (5) MINUTES INTO THE CASE, INCREASING AIRWAY PRESSURES WERE NOTED AS WELL AS A CHANGE IN THE END TIDAL CARBON DIOXIDE TRACE, WHICH WAS THOUGHT TO BE ACUTE BRONCHOSPASM [AND WAS TREATED AS SUCH]; THE PATIENT WAS REPORTED TO BE "VERY" DIFFICULT TO VENTILATE. THE SURGERY WAS COMPLETED AND THE PEDIATRIC RETRIEVAL TEAM BECAME INVOLVED IN ORDER TO STABILIZE THE PATIENT, WHO WAS TRANSFERRED TO THE NEAREST PEDIATRIC CRITICAL CARE UNIT. PRIOR TO TRANSFER OF THE PATIENT, BRONCHOSCOPY DOWN THE TUBE WAS ATTEMPTED; HOWEVER, THE ETT WAS FOUND TO BE SIGNIFICANTLY KINKED JUST ABOVE THE PATIENT¿S VOCAL CORDS. IT WAS ADDITIONALLY REPORTED, THERE HAD BEEN NO MANIPULATION OF THE PATIENT¿S HEAD DURING THE CASE. ADDITIONAL INFORMATION RECEIVED 06JUN2024 THE PATIENT REQUIRED REINTUBATION; THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 24 HOURS LATER.

  Patient problems: Respiratory Insufficiency

  MAUDE report 19571197 ↗
• MalfunctionMar 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) CUFF LEAKED "MID CASE AND WOULD NO LONGER HOLD WHEN THEY TRIED TO REFILL"; THE PATIENT WAS EXTUBATED AND REINTUBATED MID-PROCEDURE. IT WAS ADDITIONALLY REPORTED, THE ETT CUFF WORKED GREAT FOR THE FIRST 40 OR SO MINUTES PRIOR TO THE ISSUE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18874331 ↗
• DeathDec 30, 2022Material Twisted/Bent; Material Twisted/Bent

  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 3011270181-2022-00092 FOR THE ONE EVENT. REFER TO 3011270181-2022-00093 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE KINKED, CAUSING INADEQUATE VENTILATION AND THE DEVICE WAS REPLACED. THE ENDOTRACHEAL TUBE [ETT] WAS IN PLACE 16-HOURS PRIOR TO THE ETT KINKING. THE PATIENT IS DECEASED. ADDITIONAL INFORMATION RECEIVED 15-DEC-2022 STATED "AFTER SPEAKING TO BOTH THE PICU [PEDIATRIC INTENSIVE CARE UNIT] DIRECTOR AND THE PATIENT SAFETY AND QUALITY NURSE MANAGER FOR THE HOSPITAL, [THE CLINICAL NURSE CONSULTANT (CNC) HAD] BEEN INFORMED THAT [SHE WAS] UNABLE TO PROVIDE THE DATE AND CAUSE OF DEATH AT PRESENT DUE TO ABILITY OF BEING ABLE TO IDENTIFY PATIENT WITH THE INFORMATION ALREADY PROVIDED."

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

  MAUDE report 16077930 ↗
• DeathDec 29, 2022Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL 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 3011270181-2022-00092 FOR THE ONE EVENT. REFER TO 3011270181-2022-00094 FOR THE THIRD EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE KINKED, CAUSING INADEQUATE VENTILATION AND THE DEVICE WAS REPLACED. THE ENDOTRACHEAL TUBE [ETT] WAS IN PLACE 20-HOURS PRIOR TO THE ETT KINKING. THE PATIENT IS DECEASED. ADDITIONAL INFORMATION RECEIVED 15-DEC-2022 STATED "AFTER SPEAKING TO BOTH THE PICU [PEDIATRIC INTENSIVE CARE UNIT] DIRECTOR AND THE PATIENT SAFETY AND QUALITY NURSE MANAGER FOR THE HOSPITAL, [THE CLINICAL NURSE CONSULTANT (CNC) HAD] BEEN INFORMED THAT [SHE WAS] UNABLE TO PROVIDE THE DATE AND CAUSE OF DEATH AT PRESENT DUE TO ABILITY OF BEING ABLE TO IDENTIFY PATIENT WITH THE INFORMATION ALREADY PROVIDED."

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

  MAUDE report 16070031 ↗
• InjuryDec 29, 2022Material Twisted/Bent; Material Twisted/Bent

  AVANOS MEDICAL 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 3011270181-2022-00093 FOR THE SECOND EVENT. REFER TO 3011270181-2022-00094 FOR THE THIRD EVENT. IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE KINKED, CAUSING INADEQUATE VENTILATION AND NOT POSSIBLE TO PASS A SUCTION CATHETER THROUGH. PATIENT WAS INTUBATED, BUT ADEQUATE VENTILATION COULD NOT BE ESTABLISHED. THE PATIENT WAS REPORTED TO BE ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) HOWEVER, IT IS UNKNOWN IF THE REPORTED ISSUE IS WHY THE PATIENT IS ON ECMO. ADDITIONAL INFORMATION RECEIVED 14-DEC-2022 STATED THE ENDOTRACHEAL TUBE [ETT] WAS IN PLACE 6-HOURS PRIOR TO THE ETT KINKING. THE PATIENT IS CURRENTLY ON EXTRACORPOREAL LIFE SUPPORT (ECLS). THE TUBE WAS NOT ALTERED IN ANYWAY PRIOR TO THE REPORTED INCIDENT OCCURRING. THE ETT WAS SUCTIONED ONCE DURING THIS TIME. THE ETT WAS SECURED WITH AN ETAD (ENDOTRACHEAL TUBE ATTACHMENT DEVICE) AND THE POSITION WAS NOT CHANGED DURING THIS TIME. THE PATIENT WAS CHANGED TO HFOV (HIGH-FREQUENCY OSCILLATORY VENTILATION) FROM CONVENTIONAL VENTILATION

  Patient problems: Low Oxygen Saturation

  MAUDE report 16069669 ↗
• MalfunctionSep 30, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THE PATIENT WAS REINTUBATED; THE TUBE HAD BEEN IN PLACE FOR 9 HOURS AND KINKED FOLLOWING INTUBATION, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15513748 ↗
• 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 14555553 ↗
• MalfunctionMay 14, 2022Material Twisted/Bent; Material Twisted/Bent

  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 3011270181-2022-00035 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS KINKING OF THE TUBE DURING INTUBATION AND VENTILATION. THE PATIENT WAS EXTUBATED AND A SECOND ATTEMPT WAS MADE WITH A NEW DEVICE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 14403162 ↗
• MalfunctionMay 14, 2022Material Twisted/Bent; Material Twisted/Bent

  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 3011270181-2022-00034 FOR THE FIRST REPORT. IT WAS REPORTED THAT PRIOR TO THE SECOND INTUBATION ATTEMPT, THE DEVICE WAS FIRST WARMED AND THEN USED WITH A STYLET, AND AGAIN THEY REPORTED HAVING THE SAME KINKING ISSUE. AFTER THIS SECOND ATTEMPT, THE THIRD ATTEMPT WAS MADE WITH A COMPETITOR'S TUBE AND NO FURTHER ISSUES OCCURRED.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 14402976 ↗