AVANOS 44085Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00350770440859), received between Aug 19, 2020 and Jan 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED 28-JAN-2025 STATING THE PATIENT, "REQUIRED A GENERAL ANESTHETIC FOR CHANGE OF TUBE" AND WAS TRANSFERRED TO ANOTHER FACILITY FOR ACCESS FOR INTRAVENOUS (IV) FLUIDS. THE PATIENT WAS ADMITTED FOR THREE NIGHTS TO THE HEALTH FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172588 ↗
• MalfunctionJul 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  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 9611594-2023-00097 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE GASTRIC-JEJUNAL FEEDING TUBE HAD A HOLE ON THE JEJUNAL PORTION OF THE TUBE, JUST BELOW THE BALLOON. THE TUBE WAS INSERTED ON (B)(6) 2023 AND REPLACED ON (B)(6) 2023. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302430 ↗
• MalfunctionJul 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  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 9611594-2023-00096 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE GASTRIC-JEJUNAL FEEDING TUBE HAD A HOLE ON THE JEJUNAL PORTION OF THE TUBE, JUST BELOW THE BALLOON. THE TUBE WAS INSERTED ON (B)(6) 2023 AND REPLACED ON (B)(6) 2023. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302420 ↗
• MalfunctionJun 30, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL 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 9611594-2023-00092 FOR THE SECOND EVENT. IT WAS REPORTED "WHEN ADMINISTERING NUTRITION INTO JEJUNAL PORT, THE NUTRITION CAME OUT IN STOMACH." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17238880 ↗
• MalfunctionJun 30, 2023Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL 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 9611594-2023-00090 FOR THE FIRST EVENT. IT WAS REPORTED "WHEN ADMINISTERING NUTRITION INTO JEJUNAL PORT, THE NUTRITION CAME OUT IN STOMACH." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17237973 ↗
• MalfunctionAug 19, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FEEDING TUBE HAD A "SPLIT/FRACTURE IN THE TUBE OF THE JEJUNAL LIMB NEAR THE GASTRIC LIMB HOLE." WHEN CONTRAST WAS INJECTED IN THE JEJUNAL LIMB, IT WAS SEEN FLOWING INTO THE STOMACH AND NOT INTO THE JEJUNAL LIMB. NO PATIENT INJURY WAS REPORTED AND NO MEDICAL TREATMENT WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED 05-AUG-2020 INDICATED THAT THE FEEDING TUBE WAS INSERTED (B)(6) 2020 AND REMOVED ON (B)(6) 2020. IT WAS REPORTED AS "BROKEN, ASPIRATING MILK FROM G TUBE [GASTRIC TUBE]."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10424785 ↗