AVANOS 44126Recalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770441269), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 malfunction.

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

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

Break1
Fluid/Blood Leak1
Malposition of Device1

Patient problems

Granuloma1
Skin Inflammation/ Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 22, 2025Break; Fluid/Blood Leak; Malposition of Device; Break; Fluid/Blood Leak; Malposition of Device
IT WAS REPORTED "THE 1.5 WAS TOO TIGHT AND THE 2.0 I SUPPOSE IS TOO BIG BECAUSE IT SPINS." THE PATIENT IS "STILL HAVING GRANULATION TISSUE/BLEEDING ISSUES WITH THIS NEW ONE, NOT AS BAD AS BEFORE BUT STILL THERE NONETHELESS." ADDITIONAL INFORMATION RECEIVED 11-OCT-2025 STATED THE PATIENT'S TUBE "COMPLETELY BROKE ON (B)(6) 2025 WHILE THE PATIENT WAS INPATIENT WITH BACTEREMIA. IT HAD BEEN LEAKING AND GRADUALLY WORSENING EACH DAY. WHEN IT BROKE, A LARGE QUANTITY OF STOMACH ACID BEGAN TO FLOW CONTINUALLY FOR THE NEXT 8-HOURS UNTIL IT COULD BE REPLACED. IT BURNED PATIENT'S SKIN WITH THE CONSTANT ACID EXPOSURE. THE INTERVENTIONAL RADIOLOGY [DEPARTMENT] LOCATED AN AVANOS 1.7 CM STOMA LENGTH GJ LOW PROFILE TUBE. THEY COULD SEE ON THE FLUOROSCOPY SCANS DURING PROCEDURE THAT THE TUBE HAD COILED IN THE STOMACH AND WAS NOT IN THE PROPER LOCATION OF THE SMALL INTESTINES. IT WAS NOTED THE PROVIDER "THINKS THIS MAY HAVE BEEN CAUSED BY THE IMPROPERLY FITTING TUBE (TOO LARGE). IT WAS A TECHNICALLY DIFFICULT PROCEDURE LASTING ABOUT 90-MINUTES." THE SKIN AROUND STOMA WAS QUITE IRRITATED, INFLAMED, ETC. THE PHYSICIAN STATED, "FUTURE REPLACEMENTS WILL NEED TO BE EITHER GENERAL ANESTHESIA AS IT WILL TAKE
Patient problems: Granuloma; Skin Inflammation/ Irritation
MAUDE report 23364202 ↗

Device details

UDI-DI	`00350770441269`
Brand	AVANOS
Model	44126
Catalog no.	8270-22-2.0-45
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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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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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