AVANOS 44100Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastric-Jejunal Feeding Tube Kit Extension Sets · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770441009), received between Jun 8, 2020 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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.

Reports received per month

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

Recalls naming this device

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

Device problems

Material Puncture/Hole2
Device Emits Odor1
Fluid/Blood Leak1
Material Discolored1
Material Fragmentation1

Patient problems

Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1
Pain1

Recent adverse event reports

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

MalfunctionSep 30, 2026Fluid/Blood Leak; Material Puncture/Hole
It was reported the jejunal tube "has holes that allow everything to empty into the stomach."There was no reported injury.
Patient problems: Pain
MAUDE report 50942937 ↗
MalfunctionApr 3, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE "PATIENT IS CARRIER OF GASTROSTOMY BUTTON WITH JEJUNO ADVANCE" PLACEMENT. THE NUTRITION PLACED BY THE JEJUNAL ROUTE IS CROSSING INTO THE OTHER TUBE CHANNEL. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21766719 ↗
MalfunctionJun 8, 2020Material Discolored; Material Fragmentation; Device Emits Odor; Material Discolored; Material Fragmentation; Device Emits Odor
PER ADDITIONAL INFORMATION RECEIVED 22 JUN 2020, THE TUBE HAD BEEN IN PLACE FOR 239 DAYS. THE FOLLOWING MEDICATIONS WERE PROVIDED VIA THE TUBE: ATORUSATATIN, CLOPIDOGREL, ALFACALCIDOL, PARACETAMOL. THE FEED PROVIDED WAS 1000ML NUTRISON ENERGY MULTIFIBRE. THE BALLOON HAD BEEN INFLATED WITH 8ML OF FLUID. THE NEW TUBE WAS PLACED 4 MAY 2020, THE CORRECTED DAY OF EVENT. PER A STATEMENT FROM THE DISTRIBUTOR, VYGON, THE TUBE WAS DISCOLORED WITH A STRONG ODOR. THEY BELIEVE THIS IS DUE TO FUNGUS COLONIZATION OF THE TUBE.
Patient problems: Foreign Body In Patient
MAUDE report 10129142 ↗

Device details

UDI-DI	`00350770441009`
Brand	AVANOS
Model	44100
Catalog no.	8270-16-3.0-45
Company	Avanos Medical, Inc.
Product code	KNT · Tubes, gastrointestinal (and accessories)
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 15, 2020

Device type (GMDN): Jejunostomy tube

A sterile, thin, flexible, hollow tube percutaneously inserted into the jejunum, typically through puncture of the abdominal wall and stomach after distention of the gut by endoscopic methods. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and/or to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.