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Halyard 94846Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC-KEY* G Feeding Tube-14-5-2.3 · 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 10680651948462), received between Jul 20, 2017 and Sep 15, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1
  • Migration or Expulsion of Device1

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.

  • MalfunctionSep 15, 2017Break; Break

    IT WAS REPORTED THAT THE MIC KEY SPLIT IN HALF. THE PART REMAINING BEHIND IN THE PATIENT WAS PASSED RECTALLY. PER ADDITIONAL INFORMATION RECEIVED 1 SEP 2017, THE EVENT OCCURRED AFTER 21 DAYS OF USE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6870164 ↗
  • MalfunctionJul 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

    IT WAS REPORTED BY THE CAREGIVER THAT THE PATIENT PULLED THE DEVICE OUT OF THE STOMACH ON (B)(6)2017. A PORTION OF THE STEM REMAINED IN THE PATIENT'S INTESTINES. THE PATIENT WAS TAKEN TO THE DOCTOR WHO ADVISED THE CAREGIVER TO ALLOW THE PATIENT TO PASS THE BROKEN PORTION. AN X-RAY WAS TAKEN BY A GI SPECIALIST WHO CONFIRMED ABOUT AN INCH LONG STEM OF THE DEVICE WAS IN PATIENT'S INTESTINE. THE CAREGIVER STATED, THE BROKEN PORTION OF THE TUBE WAS PASSED BY THE PATIENT IN THE STOOL THREE WEEKS LATER. THE CAREGIVER STATED THAT THE PATIENT WAS SIZED 1-2 YEARS AGO, WEIGHT STABLE, AND NO GROWTH. THERE WERE NO CHANGES IN FORMULA. ANTI-INFLAMMATORY AND ANTI SEIZURE MEDICATIONS ADDED. THERE WERE 6 CC OF STERILE WATER PLACED IN THE BALLOON. THE CAREGIVER STATED THAT THE PATIENT IS CURRENTLY DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6730759 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

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Sources and updates

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