AVANOS 95649Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770956497), received between Mar 31, 2021 and Sep 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionSep 17, 2024Leak/Splash; Material Puncture/Hole; Obstruction of Flow; Leak/Splash; Material Puncture/Hole; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED THREE REPORTS THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00193 FOR THE SECOND REPORT. REFER TO 9611594-2024-00194 FOR THE THIRD REPORT. IT WAS REPORTED VIA FDA MW5157813, ¿MY SON HAD AN AVANOS MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE REPLACED ON (B)(6) 2024. IT WAS NOTED THAT FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B) (6) RADIOLOGY, IT WAS NOTED WHEN THE JEJUNAL PORT WAS INJECTED WITH CONTRAST, THE STOMACH OPACIFIED WITH CONTRAST CONFIRMING A LEAK IN THE TUBE. IT WAS ALSO NOTED THAT THE TUBE WAS CLOGGED AND THE GUIDEWIRE WAS NOT ABLE TO ADVANCE FULLY. LESS THAN A MONTH LATER ON (B)(6) 2024, THE SAME ISSUES WERE NOTED WITH FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B)(6) RADIOLOGY, IT WAS ONCE AGAIN NOTED UNDER FLUOROSCOPIC GUIDANCE, A WIRE WAS ADVANCED INTO THE INDWELLING TUBE WITH SLIGHT DIFFICULTY. THE BALLOON WAS DEFLATED AND THE INDWELLING TUBE WAS WITHDRAWN OVER THE WIRE. A HOLE WAS NOTED IN THE TUBE OF THE INDWEL

  Patient problems: Failure of Implant

  MAUDE report 20237753 ↗
• MalfunctionSep 17, 2024Leak/Splash; Material Puncture/Hole; Obstruction of Flow; Leak/Splash; Material Puncture/Hole; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED THREE REPORTS THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00192 FOR THE FIRST REPORT REFER TO 9611594-2024-00194 FOR THE THIRD REPORT IT WAS REPORTED VIA FDA MW5157814, ¿MY SON HAD AN AVANOS MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE REPLACED ON (B)(6) 2024. IT WAS NOTED THAT FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B) (6) RADIOLOGY, IT WAS NOTED WHEN THE JEJUNAL PORT WAS INJECTED WITH CONTRAST, THE STOMACH OPACIFIED WITH CONTRAST CONFIRMING A LEAK IN THE TUBE. IT WAS ALSO NOTED THAT THE TUBE WAS CLOGGED AND THE GUIDEWIRE WAS NOT ABLE TO ADVANCE FULLY. LESS THAN A MONTH LATER ON (B)(6) 2024, THE SAME ISSUES WERE NOTED WITH FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B)(6) RADIOLOGY, IT WAS ONCE AGAIN NOTED UNDER FLUOROSCOPIC GUIDANCE, A WIRE WAS ADVANCED INTO THE INDWELLING TUBE WITH SLIGHT DIFFICULTY. THE BALLOON WAS DEFLATED AND THE INDWELLING TUBE WAS WITHDRAWN OVER THE WIRE. A HOLE WAS NOTED IN THE TUBE OF THE INDWELLI

  Patient problems: Failure of Implant

  MAUDE report 20237720 ↗
• MalfunctionSep 17, 2024Leak/Splash; Material Puncture/Hole; Obstruction of Flow; Leak/Splash; Material Puncture/Hole; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED THREE REPORTS THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00192 FOR THE FIRST REPORT. REFER TO 9611594-2024-00193 FOR THE SECOND REPORT . IT WAS REPORTED VIA FDA MW5157815, ¿MY SON HAD AN AVANOS MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE REPLACED ON (B)(6) 2024. IT WAS NOTED THAT FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B) (6) RADIOLOGY, IT WAS NOTED WHEN THE JEJUNAL PORT WAS INJECTED WITH CONTRAST, THE STOMACH OPACIFIED WITH CONTRAST CONFIRMING A LEAK IN THE TUBE. IT WAS ALSO NOTED THAT THE TUBE WAS CLOGGED AND THE GUIDEWIRE WAS NOT ABLE TO ADVANCE FULLY. LESS THAN A MONTH LATER ON (B)(6) 2024, THE SAME ISSUES WERE NOTED WITH FORMULA INSERTED INTO THE JEJUNAL PORTION OF THE TUBE CAME OUT THE GASTRIC PORTION. UPON EXAM AT (B)(6) RADIOLOGY, IT WAS ONCE AGAIN NOTED UNDER FLUOROSCOPIC GUIDANCE, A WIRE WAS ADVANCED INTO THE INDWELLING TUBE WITH SLIGHT DIFFICULTY. THE BALLOON WAS DEFLATED AND THE INDWELLING TUBE WAS WITHDRAWN OVER THE WIRE. A HOLE WAS NOTED IN THE TUBE OF THE INDWE

  Patient problems: Failure of Implant

  MAUDE report 20237623 ↗
• MalfunctionMar 31, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED ON (B)(6) 2021 AND REMOVED ON (B)(6) 2021 . UPON REMOVAL, IT WAS FOUND THAT THE FEEDING TUBE WAS TORN SO THAT THE JEJUNAL FEED LEAKED INTO THE GASTRIC LUMEN. THE PHYSICIAN PERFORMED A DYE WATER TEST AND THE WATER CAME OUT OF THE GASTRIC LUMEN AND THE FARRELL BAG WAS FILLED WITH FORMULA. WHEN THE TUBE WAS REMOVED AND THE PHYSICIAN FLUSHED IT, THE WATER POURED OUT OF THE SIDE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599616 ↗