AVANOS 20-4431Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770457369), received between Oct 14, 2022 and Jul 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED, X-RAY REVEALED SMALL SHINNY ROUND PIECES IN PATIENT¿S COLON. DURING INVESTIGATION FOUND OUT THOSE PIECES MIGHT BE FROM THE NASOJEJUNAL (NJ) TUBE AS WEIGHTS IN NJ TUBE LOOKS SIMILAR TO THE PIECES TO X-RAY IMAGE. FEEDING TUBE MIGHT HAVE RUPTURED AND PIECES MOVED THROUGH. PER ADDITIONAL INFORMATION RECEIVED ON 04JUL2024, IT WAS NOT NOTICED IF THE TUBE WAS DAMAGED UPON REMOVAL. MULTIPLE ABDOMINAL X-RAYS WERE PERFORMED TO TRACK OBJECT. THE TUBE WAS IN PLACED FOR 28 DAYS. THE OBJECTS NOTED IN BOWEL ON X-RAY WERE PASSED/EXCRETED (CONFIRMED BY X-RAY). THE PATIENT IS STABLE AND DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19829584 ↗
• MalfunctionJun 24, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED "FAILURE THAT OCCURRED AT THE TIME OF PASSING THE NUTRITION FORMULA, WHERE IT IS EVIDENT THAT THERE ARE TWO OUTLETS IN THE TUBE, THROUGH WHICH THE NUTRITION [WAS] SPILLED. WHEN VERIFYING THE REPORTED DEFECT, 3 TEAR POINTS ARE CHECKED ALONG THE BODY OF THE TUBE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593325 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT, ON (B)(6) 2022, THE DOCTOR (MD) INSERTED A NASOGASTRIC (NG) TUBE IN A PATIENT INTRAOPERATIVELY. AT THE END OF THE CASE A ROUTINE X-RAY WAS TAKEN TO RULE OUT FOREIGN BODIES; THE X-RAY REVEALED THE WEIGHTED END OF THE NG TUBE WAS BROKEN INTO THE PATIENT¿S STOMACH. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15611509 ↗