AVANOS 44294Recalls & reported problems
Avanos Medical, Inc. · * MIC* Gastrostomy Feeding Tube with ENFit® Connector · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770442945), received between May 19, 2022 and May 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Collapse1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Material Rupture
IT WAS REPORTED THE "ADULT ICU (INTENSIVE CARE UNIT) NURSING DEPARTMENT REPORTS THAT A PATIENT WITH A GASTROSTOMY TUBE SURGICALLY INSERTED ON (B)(6) 2026, REQUIRED FURTHER ATTENTION BECAUSE A NURSING ASSISTANT NOTICED THE GASTROSTOMY TUBE HAD COME OUT DUE TO A RUPTURED BALLOON (A MALFUNCTION OF THE TUBE'S OWN COMPONENT DUE TO A BREAKDOWN)...THE INTENSIVIST AND GENERAL SURGEON WERE NOTIFIED, AS THE PATIENT HAD TO BE TAKEN BACK TO SURGERY TO HAVE A NEW TUBE INSERTED DUE TO THE FAILURE OF THE BALLOON IN THE FIRST TUBE." THIS A NEWLY FORMED STOMA WITH DEVICE USE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177036 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THERE WAS A NASOGASTRIC "TUBE BREAK." THE DEVICE "WAS TRACTION REMOVED IN THEATRE IN (B)(6)." THE PEG WAS IN USE FOR 18-MONTHS. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480450 ↗MalfunctionMay 19, 2022Collapse
WHEN PUTTING ENFIT SYRINGE INTO THE END OF TUBE TO CHECK RESIDUALS, THE TUBE COLLAPSES DOWN ON ITSELF. WHEN USED FOR DRAINAGE WITH ENFIT ADAPTORS IT WON'T DRAIN. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Insufficient Information
MAUDE report 14457322 ↗
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.