AVANOS 42745Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770427454), received between Aug 10, 2020 and Aug 10, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2020-00146 FOR THE SECOND REPORT. REFER TO 9611594-2020-00147 FOR THE THIRD REPORT. REFER TO 9611594-2020-00148 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE MEDICAL TEAM NOTED THAT THE EXTENSION TUBING HAD DISCONNECTED FROM THE MIC KEY FEEDING TUBE. AS A RESULT, NUTRITION LEAKED ON TO THE BED. THE PATIENT WAS RECEIVING CONTINUOUS FEED AT NIGHT DUE TO A GLYCOGEN STORAGE DISEASE TYPE 1A, AND HAD BEEN HOSPITALIZED STARTING ON (B)(6) 2020 DUE TO HYPOGLYCEMIA AND SEIZURE RELATED TO THAT CONDITION. THE TUBE HAD BEEN PLACED ON (B)(6) 2020. THERE WAS NO INJURY TO THE PATIENT. THE TUBE WAS REPLACED, AND IT WAS DETERMINED THAT IT SHOULD BE REPLACED MONTHLY. PER ADDITIONAL INFORMATION RECEIVED ON 4 AUG 2020, THE PATIENT IS NOW FINE AND WAS SENT HOME ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388149 ↗
• MalfunctionAug 10, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2020-00145 FOR THE FIRST REPORT. REFER TO 9611594-2020-00146 FOR THE SECOND REPORT. REFER TO 9611594-2020-00148 FOR THE FOURTH REPORT. IT WAS REPORTED TO THE HOSPITAL BY THE PATIENT'S FAMILY THAT THE OVERNIGHT FEED EXTENSION TUBING HAD DISCONNECTED FROM THE MIC KEY FEEDING TUBE. THIS EVENT OCCURRED BETWEEN (B)(6) 2020. THE PATIENT WAS RECEIVING CONTINUOUS FEED AT NIGHT DUE TO A GLYCOGEN STORAGE DISEASE TYPE 1A, AND HAD BEEN HOSPITALIZED STARTING ON (B)(6) 2020 DUE TO HYPOGLYCEMIA AND SEIZURE RELATED TO THAT CONDITION. THE TUBE HAD BEEN PLACED ON (B)(6) 2020. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388073 ↗
• MalfunctionAug 10, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2020-00145 FOR THE FIRST REPORT. REFER TO 9611594-2020-00146 FOR THE SECOND REPORT. REFER TO 9611594-2020-00147 FOR THE THIRD REPORT. IT WAS REPORTED TO THE HOSPITAL BY THE PATIENT'S FAMILY THAT THE OVERNIGHT FEED EXTENSION TUBING HAD DISCONNECTED FROM THE MIC KEY FEEDING TUBE. THIS EVENT OCCURRED (B)(6) 2020. THE PATIENT WAS RECEIVING CONTINUOUS FEED AT NIGHT DUE TO A GLYCOGEN STORAGE DISEASE TYPE 1A, AND HAD BEEN HOSPITALIZED STARTING ON (B)(6) 2020 DUE TO HYPOGLYCEMIA AND SEIZURE RELATED TO THAT CONDITION. THE TUBE HAD BEEN PLACED ON (B)(6) 2020. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388060 ↗
• MalfunctionAug 10, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2020-00145 FOR THE FIRST REPORT. REFER TO 9611594-2020-00147 FOR THE THIRD REPORT. REFER TO 9611594-2020-00148 FOR THE FOURTH REPORT. IT WAS REPORTED TO THE HOSPITAL BY THE PATIENT'S FAMILY THAT THE OVERNIGHT FEED EXTENSION TUBING HAD DISCONNECTED FROM THE MIC KEY FEEDING TUBE. THIS EVENT OCCURRED (B)(6) 2020. THE PATIENT WAS RECEIVING CONTINUOUS FEED AT NIGHT DUE TO A GLYCOGEN STORAGE DISEASE TYPE 1A, AND HAD BEEN HOSPITALIZED STARTING ON (B)(6) 2020 DUE TO HYPOGLYCEMIA AND SEIZURE RELATED TO THAT CONDITION. THE TUBE HAD BEEN PLACED ON (B)(6) 2020. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388008 ↗