AVANOS 44160Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770441603), received between Feb 13, 2025 and Feb 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Caustic/Chemical Burns1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TUBE "IS LEAKING PROFUSELY"- LEAKING AROUND TUBE FROM STOMA- AND THAT HE IS GETTING "BURNS ON MY BELLY BECAUSE OF THE GASTRIC JUICES LEAKING; RATING DISCOMFORT '7-8' DUE TO THE SKIN IRRITATION. STATES MD [MEDICAL DOCTOR] HAS ADVISED HIM LEAKAGE IS NORMAL BUT [PATIENT] IS NOW CHANGING GAUZE UNDERNEATH [EVERY] 30-40 MIN DUE TO LEAKAGE. STATES HAS WOUND CARE RN [REGISTERED NURSE] AT HOME 3 TIMES/[WEEK] AND SHE IS HELPING MANAGE THE IRRITATED AREAS. REPORTS HAS EDEMA AS COMORBIDITY; ADVISED THAT THIS MAY BE AFFECTING SIZING FOR TUBE. PER [PATIENT], MD HAS NOT CHECKED ACTUAL STOMA LENGTH BUT CHANGED INTERNAL DIAMETER OF TUBE LAST YEAR." ADDITIONAL INFORMATION RECEIVED 06-FEB-2025 STATED IT IS BELIEVED "THE VALVE CAME APART IN TUBE AND THAT IS WHY IT LEAKED- REPORTS 'IT WAS SQUIRTING WATER' WHEN SYRINGE WAS DISCONNECTED AND LOSING UP TO 2-3 ML DAILY. STATES THAT REPLACEMENT TUBE HAS BEEN FUNCTIONING WITHOUT ISSUE THUS FAR."
Patient problems: Caustic/Chemical Burns
MAUDE report 21380150 ↗
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- 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 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
- 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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