Halyard 95667Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC-KEY* GJ Feeding Tube-18-3.0-45.0-7-10 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956672), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2018Break; Break
IT WAS REPORTED THAT A PATIENT'S GJ TUBE BROKE INSIDE OF HIM. THE PATIENT WAS SCHEDULED FOR A 3-MONTH ROUTINE TUBE CHANGE. THE GROUP HOME NOTED NO ISSUES WITH THE TUBE. WHEN A WIRE WAS PUT IN AND NO RESISTANCE WAS FELT, IT WAS AT THAT TIME WHEN THEY WERE USING FLUOROSCOPY THAT IT WAS DISCOVERED THE J-TUBE DETACHED FROM THE G-TUBE. THEY WERE ABLE TO LOCATE THE DETACHED PORTION AND REMOVED IT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE PATIENT WAS AN OUTPATIENT FROM A GROUP HOME WITH CEREBRAL PALSY. IT WAS NOTED THAT THE PATIENT LEFT IN THE SAME CONDITION THAT HE CAME TO THEM IN, AND EXPERIENCED NO INJURY FROM THE TUBE. ON (B)(6) 2018, THE CUSTOMER FORWARDED AVANOS MEDICAL A COPY OF THE MEDWATCH USER FACILITY REPORT THEY FILED REFERENCE (B)(4): "ON (B)(6) 2018, THE PATIENT HAD A SCHEDULED GASTROJEJUNOSTOMY TUBE PLACEMENT. THE EXCHANGE OF THE 18 FRENCH GASTROJEJUNOSTOMY TUBE WENT AS PLANNED. APPROPRIATE POSITION WAS CONFIRMED WITH CONTRAST INJECTION. RETENTION BALLOON WAS THEN INFLATED. NO COMPLICATIONS WERE NOTED. PATIENT SENT BACK TO GROUP HOME RESIDENCE. THE PATIENT WAS SCHEDULED FOR (B)(6), FOR THE NEXT ROUTINE GASTROJEJUNOSTOMY TUBE REPLACEMENT. THE GROUP HOME
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7964623 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page