AVANOS 40-8366Recalls & reported problems
Avanos Medical, Inc. · CORFLO* Nasogastric/Nasointestinal Pediatric Feeding Tube with Stylet with ENFit® Connector · Class 2
Quick summary
This Avanos CORFLO pediatric feeding tube is used to deliver nutrition through the nose into the stomach or intestine. The 41 reports mostly describe leaks, breaks, holes, and tubes bending or being misplaced; some mention fragments left in patients, vomiting, discomfort, or nausea. There were no deaths and 2 injuries, and no recalls name this device. Reports rose from 4 in the previous 12 months to 31 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00350770460369), received between Apr 13, 2022 and Aug 18, 2026 — classified as 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (12 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash12
- Break11
- Material Puncture/Hole7
- Crack3
- Malposition of Device3
- Fluid/Blood Leak2
- Material Integrity Problem2
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Foreign Body In Patient4
- Insufficient Information4
- Vomiting3
- Discomfort2
- Nausea2
- Irritability1
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Complete Blockage
Patient problems: Irritability
MAUDE report 50302992 ↗MalfunctionAug 12, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217229 ↗MalfunctionJul 17, 2026Leak/Splash; Malposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855936 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847121 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847117 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847115 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847113 ↗MalfunctionJul 16, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25847112 ↗MalfunctionJul 15, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825773 ↗MalfunctionJul 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825772 ↗MalfunctionJul 15, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825758 ↗MalfunctionJul 14, 2026Material Puncture/Hole; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25816974 ↗MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786836 ↗MalfunctionJul 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785392 ↗MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785378 ↗MalfunctionJul 10, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785340 ↗MalfunctionJul 6, 2026Leak/Splash
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00542 FOR THE FIRST REPORT. REFER TO 9611594-2026-00543 FOR THE SECOND REPORT. IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS FOUND TO BE LEAKING NEAR THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718528 ↗MalfunctionJul 6, 2026Leak/Splash
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00542 FOR THE FIRST REPORT. REFER TO 9611594-2026-00543 FOR THE SECOND REPORT . IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS FOUND TO BE LEAKING NEAR THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718511 ↗MalfunctionJul 6, 2026Leak/Splash; Material Puncture/Hole
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2026-00480 FOR THE FIRST REPORT. REFER TO 9611594-2026-00482 FOR THE THIRD REPORT. REFER TO 9611594-2026-00483 FOR THE FOURTH REPORT. IT WAS REPORTED THAT A NASOGASTRIC TUBE WAS LEAKING FROM A SMALL HOLE NEAR THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718506 ↗MalfunctionJul 6, 2026Material Twisted/Bent
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2026-00480 FOR THE FIRST REPORT. REFER TO 9611594-2026-00481 FOR THE SECOND REPORT . REFER TO 9611594-2026-00482 FOR THE THIRD REPORT . IT WAS REPORTED THAT A NASOGASTRIC TUBE KINKED WHEN THE STYLET WAS REMOVED. THE TUBE WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718504 ↗MalfunctionJun 19, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT AN NG TUBE BALLOONED DURING USE, CONFIRMED VIA FLUOROSCOPY, AND REQUIRED REMOVAL AND REPLACEMENT OF THE TUBE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565689 ↗MalfunctionJun 16, 2026Break
THE CUSTOMER REPORTED THAT A FEEDING TUBE BROKE INSIDE A PATIENT DURING USE.
Patient problems: Insufficient Information
MAUDE report 25519895 ↗MalfunctionJun 1, 2026Material Puncture/Hole
IT WAS REPORTED THAT A HOLE WAS NOTED IN NASOGASTRIC TUBING BETWEEN THE FEEDING TUBE AND FEEDING PORT CONNECTION. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25354504 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT AN NG TUBE LEAKED AT THE BASE UPON INSERTION, AND THE DEVICE WAS REMOVED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. EVENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25229294 ↗MalfunctionMar 10, 2026Fluid/Blood Leak
IT WAS REPORTED THE PATIENT'S NASOGASTRIC TUBE WAS FOUND TO BE LEAKING AT THE "MOST DISTAL POINT OF SILASTIC TUBING (RIGHT NEXT TO PORTS). NO IMMEDIATE HARM TO PATIENT, FEED DELAYED BY 1-HOUR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24563284 ↗
Other Tubes, gastrointestinal (and accessories) devices
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- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.