AVANOS 44579Recalls & reported problems
Avanos Medical, Inc. · MIC* Gastric-Jejunal Feeding Tube Kit with ENFit® Connector - Endoscopic/Radiologic Placement · 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 00350770445793), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2025Material Rupture; Material Rupture
IT WAS REPORTED THE DEVICE WAS INSERTED ON (B)(6) 2025. ON (B)(6) 2025 THAT A BALLOON WAS PUNCTURED/POROUS IN A RECENTLY PLACED STOMA SITE. A NEW PROCEDURE UNDER GENERAL ANESTHESIA WAS NEEDED TO REPLACE THE GASTROSTOMY TUBE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-OCT-2025 STATING A NEW PROCEDURE WAS REQUIRED UNDER GENERAL ANESTHESIA AND SCHEDULED FOR REINSERTION OF THE GASTROSTOMY TUBE. THE TUBE REPLACEMENT WAS PLANNED. PENDING THE REOPERATION, THE TUBE WAS SECURED TO THE PATIENT'S SKIN. ADDITIONAL INFORMATION RECEIVED 03-NOV-2025 STATING THE ADDITIONAL PROCEDURE REQUIRED WAS AN "ORGANIZED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY." ADDITIONAL INFORMATION RECEIVED 04-NOV-2025 STATING ACCORDING TO THE PATIENT'S "STATEMENTS, THE STOMA SITE WAS PLACED RECENTLY, BUT I DO NOT HAVE THE EXACT DATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23661042 ↗
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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