Halyard 95647Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC-KEY* GJ Feeding Tube-16-2.7-45.0-7-10 · Class 2 · Implant
Data updated Oct 13, 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 10680651956474), received between Jan 20, 2017 and Dec 18, 2017 — classified as 2 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.
Most reported problems
Device problems
- Break1
- Device Operates Differently Than Expected1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2017Break; Break
IT WAS REPORTED BY THE DISTRIBUTOR THAT THE HUB OF THE DEVICE SHEARED AWAY FROM THE TUBE. THE PATIENT REQUIRED AN ENDOSCOPY TO RETRIEVE THE REST OF THE TUBE PRIOR TO REPLACEMENT OF THE DEVICE. PER ADDITIONAL INFORMATION RECEIVED 12 DEC 2017, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL FOLLOW UP AND WAS DISCHARGED FROM THE HOSPITAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7125422 ↗MalfunctionJan 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE MIC-KEY JEJUNAL FEEDING TUBE PORT WAS FEEDING INTO THE PATIENT'S STOMACH. BECAUSE OF THE PATIENT'S CONDITION, THIS COULD CAUSE TO PATIENT TO BECOME VERY SICK. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: No Information
MAUDE report 6267357 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page