Halyard 94843Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC-KEY* G Feeding Tube-14-5-1.7 · Class 2 · Implant
All models of Halyard (232)
Data updated Oct 18, 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 10680651948431), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation 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 18, 2026.
Most reported problems
Device problems
- Deflation Problem1
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.
MalfunctionAug 10, 2018Deflation Problem; Deflation Problem
IT WAS REPORTED A PARENT WAS UNABLE TO DEFLATE THE PATIENT¿S FEEDING TUBE. THE PARENT PLACED AN ADDITIONAL 1CC OF WATER IN THE BALLOON A COUPLE OF DAYS AGO WHICH CAUSED THE TUBE TO BECOME TIGHT. THE PATIENT VISITED THE DOCTOR BECAUSE IRRITATION DEVELOPED AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND SENT HOME. THE PARENT HAD ATTEMPTED TO REMOVE THE WATER FROM THE DEVICE USING A LUER SLIP SYRINGE AND ALSO TRIED RELEASING WATER WITH A PAPER CLIP. THE PARENT WAS UNABLE TO DEFLATE THE BALLOON. THE PARENT WAS ADVISED TO CONSULT PHYSICIAN FOR ASSISTANCE. ADDITIONAL INFORMATION RECEIVED ON 17-JUL-2018 FROM THE PARENT STATING THE PATIENT WAS TAKEN TO THE GENERAL SURGEONS OFFICE ON (B)(6) 2018 TO HAVE THE TUBE REPLACED. THE STAFF ATTEMPTED TO DEFLATE THE BALLOON USING A NEEDLE TO PENETRATE THE BALLOON TRACT. AN ATTEMPT WAS ALSO MADE MAKING A SMALL INCISION IN THE FEEDING TUBE NEAR THE BALLOON INFLATION PORT. NEITHER ATTEMPTS WORKED. THE NURSE PRACTITIONER ATTEMPTED TO PULL THE TUBE OUT WITH BALLOON FULL, HOWEVER THIS ATTEMPT WAS UNSUCCESSFUL. THE TOP OF THE FEEDING TUBE WAS THEN CUT OFF AND THE FEEDING TUBE STEM FELL INTO THE PATIENT'S STOMACH. AT THAT TIME THE PARENT WAS WAITING FOR THE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7774459 ↗
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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