AVANOS 40-4431Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770460185), received between Apr 15, 2022 and May 23, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE PATIENT'S, "NG [NASOGASTRIC TUBE] WAS NEARLY FULLY PULLED OUT, WITH TUBE FEED STILL RUNNING AT 10 ML/HR. TUBE FEED STOPPED IMMEDIATELY, NG FULLY REMOVED. THE REASON THE [PATIENT] TUBE FEED KEPT RUNNING WITH THE NG PARTIALLY REMOVED WAS BECAUSE THE WEIGHTED, WIDER TIP OF THE NG WAS STUCK IN THE NASOPHARYNX AND REQUIRED SOME DECENT MANIPULATION TO FULLY REMOVE." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081887 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED "CORFLO TUBE [BROKE] APART INSIDE PATIENT. PATIENT HAD TUBE IN FOR 33-DAYS." THE "PATIENT IS VERY SICK NOW AND [THE CLINICIANS] WERE LOOKING FOR SOURCE SO DID A CT SCAN AND SAW SOMETHING WRONG." ADDITIONAL INFORMATION RECEIVED 17-JUN-2024 STATING "THE PATIENT DID EXPERIENCE LEUKOCYTOSIS WHICH PEAKED WHEN IT IS ASSUMED THE TUBE FIRST BROKE ((B)(6) 2024). PATIENT HAS HAD TO UNDERGO SERIAL IMAGING TO SEE WHERE THE RETAINED PART OF THE TUBE HAS MIGRATED. AT THIS TIME DUE TO PATIENT CONDITION, WE ARE UNDERGOING CONSERVATIVE MANAGEMENT, BUT SURGICAL REFERRAL HAS BEEN RECOMMENDED BY GI (GASTROINTESTINAL) AS THE PART IS NOT REACHABLE BY ENDOSCOPIC MEANS." THE USER FACILITY CLINICIAN HAS THE TOP HALF OF THE TUBE BUT AS STATED ABOVE THE BOTTOM HALF REMAINS IN THE PATIENT. NO MEDICAL INTERVENTION HAS OCCURRED AT THIS TIME.

  Patient problems: Foreign Body In Patient; High White Blood Cell Count

  MAUDE report 19593848 ↗
• MalfunctionJul 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED, A PATIENT PULLED THE NASOGASTRIC TUBE (NGT) TUBE OUT. APPROXIMATELY FOUR INCHES OF THE DISTAL PORTION OF THE NGT BROKE OFF IN THE STOMACH. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED TO REMOVE THE REMAINING PORTION OF THE NGT FROM THE PATIENT'S STOMACH. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17324398 ↗
• MalfunctionApr 15, 2022Break; Break

  IT WAS REPORTED THAT A NASOGASTRIC (NG) TUBE BROKE IN TWO PIECES AFTER 15 DAYS IN PLACE. THE BROKEN TUBE WAS DISCOVERED WHEN FEEDING CONTENTS WERE NOTED IN THE PATIENT'S MOUTH AND NARES; AN X-RAY OF THE ABDOMEN WAS PERFORMED. UPON REMOVAL OF THE TUBE THE DISTAL PORTION OF THE TUBE WAS RETAINED WITHIN THE PATIENT. AN EGD (ESOPHAGOGASTRODUODENOSCOPY) WAS PERFORMED BY GASTROENTEROLOGY TO RETRIEVE THE RETAINED PORTION OF THE NG TUBE; A NEW FEEDING TUBE WAS PLACED. ADDITIONAL INFORMATION RECEIVED 23MAR2022; THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14119635 ↗