Halyard 94967Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC* J Feeding Tube-12-2-3 · Class 2 · Implant
All models of Halyard (232)
Data updated Oct 18, 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 10680651949674), received between Feb 18, 2019 and Mar 7, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2019Break; Break
IT WAS REPORTED THE FEEDING TUBE BROKE WITH NO REPORTED PATIENT INJURY ADDITIONAL INFORMATION RECEIVED 20-FEB-2019 STATED THE J-TUBE BROKE AFTER 2-WEEKS OF PATIENT USE. THE DISTAL PORTION OF THE TUBE BROKE OFF INSIDE ONE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8400586 ↗MalfunctionFeb 18, 2019Break; Break
IT WAS REPORTED VIA USER FACILITY REPORT # (B)(4): "J TUBE BROKE INTO 3 PIECES DURING INSERTION. IT BROKE WHILE INSIDE PT. THE SURGEON USED A GUIDE WIRE TO REMOVE FROM PT. J TUBE INSERTION. DEVICE FAILED." NO PATIENT INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8348917 ↗
Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices
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- 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-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-05090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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