AVANOS 44089Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770440897), received between May 19, 2020 and May 7, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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 · FDA record ↗

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.

• MalfunctionMay 7, 2021Fluid/Blood Leak; Material Perforation; Fluid/Blood Leak; Material Perforation

  IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL TWO AND A HALF WEEKS AFTER REPLACEMENT OF THE TUBE DUE TO VOMITING WHICH OCCURRED WHEN THE JEJUNAL CONNECTOR WAS BEING USED FOR FEEDING. THE BALLOON WAS DEFLATED AND THE FEEDING TUBE WAS INSPECTED. A PERFORATION OF THE TUBING WAS FOUND JUST BELOW THE BALLOON, IN THE AREA BETWEEN THE STOMACH AND THE DUODENUM, RESULTING IN A POSSIBLE LEAK INTO THE STOMACH OF FEED INTENDED FOR THE JEJUNUM. A NEW FEEDING TUBE WAS PLACED. PER ADDITIONAL INFORMATION RECEIVED 19 APR 2021, AFTER THE CHANGING OUT OF THE FEEDING TUBE, "EVERYTHING IS OK."

  Patient problems: Vomiting

  MAUDE report 11790810 ↗
• MalfunctionAug 24, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  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 9611594-2020-00163 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE DEVICE WAS PLACED (B)(6) 2020 AND REMOVED (B)(6) 2020 DUE TO "ASPIRATING FROM G [GASTROSTOMY TUBE], RUPTURED." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AVANOS REPRESENTATIVE ON (B)(6) 2020 INDICATED THERE IS A CLEAR SPLIT IN THE JUNCTION BETWEEN THE JEJUNAL AND GASTRIC LINES OF THE FEEDING TUBE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445880 ↗
• MalfunctionAug 24, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  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 9611594-2020-00164 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED (B)(6) 2020 AND REMOVED (B)(6) 2020 DUE TO "GJ [GASTROJEJUNAL TUBE ASPIRATING MILK BACK FROM GASTRIC PORT WHEN JEJ [JEJUNAL] FED. REMOVED AND TESTED AND WHEN FLUSHED THROUGH JEJ PORT, FEED COMES OUT OF GASTRIC TUBE. REMOVED AND FLUSHED WATER THROUGH JEJ PORT AND CLEARLY ABLE TO SEE IT COME OUT OF GASTRIC HOLE." TUBE REMOVED AND REPLACED WITH LOW PROFILE BUTTON. NO PATIENT INJURY WAS REPORTED. THE AVANOS REPRESENTATIVE STATED "I ATTACHED EXTENSION SETS TO BOTH OUTLETS, I CLAMPED THE JEJUNAL END NEAR THE STRIPE AWAY FROM THE GASTRIC OUTLET. I THEN PLACED IN WATER AND WAS ABLE TO ASPIRATE WATER VIA THE JEJUNAL PORT. THERE IS A LEAK BETWEEN THE GASTRIC AND JEJUNAL TUBES." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445826 ↗
• MalfunctionMay 19, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE GASTROJEJUNAL (GJ) TUBE WAS PLACED (B)(6) 2020 AND REMOVED (B)(6) 2020. THE CUSTOMER STATED, "GJ TUBE ASPIRATING MILK BACK FROM GASTRIC POT [PORT] WHEN JEJ [JEJUNAL] FED. MUM [MOTHER] REPORTS BEING ABLE TO ASPIRATE FEED BACK FROM GASTRIC PORT. SEEN IN PEG CLINIC AND PLAN TO REMOVE. TUBE REMOVED AND TESTED AND WHEN FLUSHED THROUGH JEJ PORT, FEED COMES OUT GASTRIC HOLE." THE CUSTOMER ALSO STATED "YOU CANNOT SEE ANY SPLIT IN THE TUBE BUT WHEN THE TUBE IS FLUSHED, YOU CAN CLEARLY SEE WATER COME OUT OF THE GASTRIC HOLE WHEN FLUSHED THROUGH THE JEJ PORT." NO PATIENT INJURY WAS REPORTED. THE CUSTOMER PROVIDED A PHOTO OF THE DEVICE ON (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10072320 ↗