Halyard 95637Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC-KEY* GJ Feeding Tube-16-1.7-30.0-3-5 · Class 2 · Implant
All models of Halyard (232)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 10680651956375), received between Aug 4, 2017 and Jan 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2019Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PATIENT INFUSED DUOPA FOR 24 HOURS, AND WHEN IT WAS TIME TO CHANGE THE CASSETTE, THE PATIENT NOTICED THAT MORNING THAT HE HAD CONNECTED THE DUOPA TO THE G-PORT, AND MEDICATION INFUSED VIA THE G-PORT TO THE J-PORT THROUGHOUT THE DAY. IT WAS ADVISED THAT THE PATIENT FLUSH THE TUBING AND CONNECT THE DUOPA J-PORT, AND CONTACT A NEUROLOGIST WITH ANY ADVERSE EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8253861 ↗MalfunctionAug 4, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A 16FR GJ FEEDING TUBE WHERE THE JEJUNAL PORT MARKER WAS SWITCHED WITH THE GASTRIC PORT MARKER WITH NO REPORTED INJURY AND NO REPORTED USE WITH A PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 6766721 ↗
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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