AVANOS 40-9228Recalls & reported problems

Avanos Medical, Inc. · CORFLO* Nasogastric/Nasointestinal Feeding Tube with Stylet with ENFit® Connector · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770460390), received between Jul 24, 2024 and Aug 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Complete Blockage1
Material Puncture/Hole1

Patient problems

Cardiac Arrest1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 7, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THE NASOGASTRIC "(NG) [TUBE} ON PATIENT WAS BLOCKED, RN'S [REGISTERED NURSES] WERE ATTEMPTING TO UNBLOCK NG. NG WAS ABLE TO BE UNBLOCKED BUT PATIENT WENT UNRESPONSIVE IMMEDIATELY AFTER. CODE BLUE WAS CALLED. APPROXIMATELY 45-MINUTES OF CODE WAS RUN. UPON ARRIVAL TO PICU [PEDIATRIC INTENSIVE CARE UNIT] POST CODE, X-RAY WAS DONE AND NG WAS SHOWN TO BE DEFECTIVEING WAS REMOVED FROM PATIENT, IT WAS NOTED TO HAVE A DEFECT." THE DEVICE WAS ORIGINALLY INSERTED ON (B)(6) AND REMOVED ON (B)(6) DURING THE CRITICAL INCIDENT.
Patient problems: Cardiac Arrest
MAUDE report 22744131 ↗
MalfunctionJul 24, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED, ¿STAFF ADVISE THIS CATHETER WAS INSERTED INTO A PAEDIATRIC PATIENT BY AN EXPERIENCED STAFF MEMBER, UNDER MEDICAL SUPERVISION. FEEDBACK IS THAT GUIDEWIRE APPEARED TO BE IN CORRECT POSITION PRIOR TO INSERTION AND NO RESISTANCE FELT WHILE INSERTION IN PROGRESS. GUIDEWIRE WAS LEFT IN PLACE IN THE TUBE UNTIL POSITION CHECK POST INSERTION WAS DONE UNDER X-RAY. THE ANOMALY WAS THEN NOTICED BY THE MEDICAL STAFF WHO ASKED FOR IT TO BE PULLED OUT. ONCE NASOGASTRIC (NG) REMOVED, IT WAS CLEAR THE GUIDEWIRE HAD PIERCED THE TUBE. NO EVIDENCE OF PATIENT HARM AS A RESULT OF THIS ANOMALY.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19818036 ↗

Device details

UDI-DI	`00350770460390`
Brand	AVANOS
Model	40-9228
Company	Avanos Medical, Inc.
Product code	KNT · Tubes, gastrointestinal (and accessories)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Aug 17, 2020

Device type (GMDN): Nasogastric feeding tube

A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.

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All Tubes, gastrointestinal (and accessories) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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