AVANOS 94815Recalls & reported problems
Avanos Medical, Inc. · * MIC* Gastrostomy Feeding Tube · Class 2 · Implant
- 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 00350770948157), received between Mar 2, 2023 and Feb 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
- Leak/Splash1
- Migration1
Patient problems
- Insufficient Information1
- 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.
MalfunctionFeb 23, 2026Fluid/Blood Leak; Device Dislodged or Dislocated
IT WAS REPORTED, "TUBE WAS PLACED INITIALLY USING AN IPK UNDER ENDOSCOPIC CONTROL. AFTER 3 DAYS PARENTS NOTICED THAT THE TUBE FELL FROM THE STOMA TRACT. BALLOON WAS EMPTY. THEY ADDED 5 ML OF WATER AND NOTICED LEAKAGE FROM THE BALLOON PORT. THEY PUT A HOME-MADE CAP TO PREVENT THE BALLOON PORT FROM LEAKAGE." NO INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24420332 ↗MalfunctionMar 2, 2023Leak/Splash; Migration; Leak/Splash; Migration
IT WAS REPORTED THAT THE BALLOON LEAKED AND THE FEEDING TUBE WAS MALPOSITIONED. IT WAS FLOATING IN THE RETROPERITONEUM. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16472122 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.