AVANOS 44576Recalls & reported problems
Avanos Medical, Inc. · MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Endoscopic/Radiologic Placement · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00350770445762), received between Feb 27, 2026 and Mar 4, 2026 — classified as 2 malfunctions.
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. 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
- Fluid/Blood Leak1
- Obstruction of Flow1
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.
MalfunctionMar 4, 2026Obstruction of Flow
IT WAS REPORTED, "THE JEJUNAL EXTENSION BROKE UNDER THE BALLOON, CAUSING A LEAK IN THE GASTRIC LUMEN." NO INJURY REPORTED. THE TUBE WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 24506078 ↗MalfunctionFeb 27, 2026Fluid/Blood Leak
IT WAS REPORTED THERE WAS AN "OBSTRUCTION AND BREAKAGE OF THE JEJUNAL EXTENSION NEAR THE BALLOON DURING INFUSION OF THE MIXTURE INTO THE GASTRIC LUMEN.¿ ADDITIONAL INFORMATION CLARIFICATION RECEIVED 09-FEB-2026 NOTED THE USER "REPORTS OBSTRUCTION OF THE JEJUNAL EXTENSION, CAUSING RUPTURE OF THE JEJUNAL EXTENSION ITSELF AND THEREFORE LEAKAGE OF FLUID INTO THE GASTRIC LUMEN." NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472161 ↗
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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