Halyard 95493Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC-KEY* GJ Feeding Tube-16-1.2-15.0-3-5 · Class 2 · Implant
All models of Halyard (232)
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 10680651954937), received between Feb 9, 2017 and Feb 9, 2017 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Caustic/Chemical Burns1
- Distress1
- Feeding Problem1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER SON, WHO HAS A CHRONIC KIDNEY DISEASE, HAD A GASTROJEJUNOSTOMY (GJ) TUBE PLACED AND THEN AFTERWARD EXPERIENCED RETCHING, BLEEDING INTO THE DRAIN BAG, GROANING, GAGGING UP CLOTS, AND BURNING SKIN ON THE NECK FROM THE ACID. THE HOSPITAL PERFORMED AN XRAY AND CONFIRMED THAT THE FEEDING TUBE WAS PLACED PROPERLY AND TOLD THE MOTHER THE SYMPTOMS WERE DUE TO THE PATIENT'S SEVERE REFLUX. BECAUSE OF THE CHILD'S REACTION, HOWEVER, THE TUBE WAS REMOVED AND REPLACED WITH A MIC KEY BUTTON AND ALL SYMPTOMS HAVE RESOLVED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Caustic/Chemical Burns; Distress; Feeding Problem; No Code Available; Pain
MAUDE report 6315892 ↗
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- 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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