AVANOS 94884Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770948843), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Fluid Discharge1
- Granuloma1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Leak/Splash
THE PARENT REPORTED LEAKAGE FROM THE GASTROSTOMY TUBE DURING USE, WITH MILK LEAKING ONTO THE CHILD. THE CHILD EXHIBITED A RED RASH, DISCHARGE AROUND THE STOMA, AND POSSIBLE OLD BLOOD. GRANULATION TISSUE WAS PRESENT, AND THE MANAGING PHYSICIAN HAD PRESCRIBED TOPICAL OINTMENT. THE CHILD EXPERIENCED PAIN EACH TIME THE TUBE WAS CLEANED. THE PARENT ADJUSTED THE BALLOON FILL VOLUME FROM 10 MILLILITERS TO 5 MILLILITERS IN AN ATTEMPT TO REDUCE DISCOMFORT, BUT SYMPTOMS PERSISTED. LEAKAGE FROM THE STOMA CONTINUED, AND THE PARENT EXPRESSED CONCERN THAT THE ISSUE MAY BE RELATED TO THE GASTROSTOMY TUBE SIZE OR ANOTHER UNDERLYING PROBLEM. THE PARENT SOUGHT A SECOND MEDICAL OPINION. A MATURE STOMA WAS REPORTED.
Patient problems: Fluid Discharge; Granuloma; Pain
MAUDE report 24521959 ↗
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
- 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
- NutraGlide Nasal Feeding Tube ENFT-06055-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 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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