AVANOS 35118Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038351186), received between Sep 24, 2021 and Mar 7, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3011270181-2026-20001 FOR THE FIRST REPORT. REFER TO 3011270181-2026-20003 FOR THE THIRD REPORT. REFER TO 3011270181-2026-20004 FOR THE FOURTH REPORT. IT WAS REPORTED, THE BALLON DID NOT REMAIN INFLATED AND THE PATIENT HAD TO BE REINTUBATED. 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 24540580 ↗
• MalfunctionMar 7, 2026Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2026-20001 FOR THE FIRST REPORT. REFER TO 3011270181-2026-20002 FOR THE SECOND REPORT. REFER TO 3011270181-2026-20004 FOR THE FOURTH REPORT. IT WAS REPORTED, THE BALLON DID NOT REMAIN INFLATED AND THE PATIENT HAD TO BE REINTUBATED. 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 24540386 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 3011270181-2026-20002 FOR THE SECOND REPORT. REFER TO 3011270181-2026-20003 FOR THE THIRD REPORT. REFER TO 3011270181-2026-20004 FOR THE FOURTH REPORT. IT WAS REPORTED, THE BALLON DID NOT REMAIN INFLATED AND THE PATIENT HAD TO BE REINTUBATED. 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 24539481 ↗
• InjuryDec 16, 2021Complete Blockage; Complete Blockage

  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 3011270181-2021-00059 FOR THE SECOND EVENT. REFER TO 3011270181-2021-00060 FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS DIFFICULTY SUCTIONING THE PATIENT AND PASSING THE SUCTION CATHETER THROUGH THE MICROCUFF ENDOTRACHEAL TUBE (ETT). THE PATIENT WAS INTUBATED WITH THE MICROCUFF ENDOTRACHEAL TUBE (ETT) ON THE MORNING OF (B)(6) 2021. ON (B)(6) 2021 AT 1715 THE PATIENT BECAME BRADYCARDIC WITH A HEART RATE IN THE 60¿S HEART BEATS PER MINUTE. THE PATIENT'S HEART RATE "DROPPED TO THE 30¿S" WITH LOSS OF PULSES AND OXYGEN DESATURATIONS. A CODE BLUE ALERT WAS CALLED AND CHEST COMPRESSIONS WERE STARTED. THE PATIENT WAS EXTUBATED AND THE MICROCUFF TUBE WAS REPLACED. THE PATIENT IMPROVED WITH VENTILATION.

  Patient problems: Bradycardia; Cardiac Arrest; Low Oxygen Saturation; Respiratory Arrest

  MAUDE report 13021379 ↗
• InjuryDec 16, 2021Complete Blockage; Complete Blockage

  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 3011270181-2021-00058 FOR THE FIRST EVENT. REFER TO 3011270181-2021-00059 FOR THE SECOND EVENT. IT WAS REPORTED THE PATIENT EXPERIENCED POOR VENTILATION AFTER INTUBATION. THE ETT WAS ADVANCED FROM 22 TO 25 WITH NO CHANGES NOTED ON THE X-RAY. THERE WAS DIFFICULTY SUCTIONING THE PATIENT AND PASSING THE SUCTION CATHETER THROUGH THE MICROCUFF ENDOTRACHEAL TUBE (ETT). THE CLINICIANS REINSERTED THE STYLET TO ASSESS PATENCY AND THE DEVICE WOULD NOT ADVANCE PAST THE ETT SECTION IN THE BACK OF THE PATIENT'S MOUTH. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 13021345 ↗
• InjuryDec 16, 2021Complete Blockage; Complete Blockage

  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 (B)(4) FOR THE FIRST EVENT. REFER TO (B)(4) FOR THE THIRD EVENT. IT WAS REPORTED THERE WAS DIFFICULTY SUCTIONING THE PATIENT AND PASSING THE SUCTION CATHETER THROUGH THE MICROCUFF ENDOTRACHEAL TUBE (ETT). THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE. THE DEVICE WAS REMOVED AND REPLACED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 13021281 ↗
• MalfunctionSep 24, 2021Collapse; Material Twisted/Bent; Collapse; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING SURGICAL PROCEDURE ON A PATIENT'S FOOT, THE PHYSICIAN APPRECIATED WHAT SEEMED TO BE AN AIRWAY OBSTRUCTION. THE [PHYSICIAN] INITIALLY ASSUMED THERE TO BE A SPUTUM PLUG, SO THEY ATTEMPTED TO REMOVE. THE ETT [ENDOTRACHEAL TUBE] WOULD NOT CLEAR, SO THEY INSERTED A BRONCHOSCOPE AND FOUND THAT THE ETT HAD KINKED/COLLAPSED IN THE PATIENT'S AIRWAY. THEY WERE UNABLE TO RESOLVE THE ISSUE, SO THEY EXTUBATED AND REINTUBATED WITH A NEW ETT. THERE WERE NO REPORTS OF PATIENT HARM AND THE PROCEDURE WAS ABLE TO BE COMPLETED."

  Patient problems: Unintended Extubation

  MAUDE report 12530460 ↗