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Halyard 94917Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC-KEY* G Feeding Tube-24-5-2.5 · 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
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651949179), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 death.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Abdominal Distention1
  • Death1
  • Skin Tears1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • DeathOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY THE DISTRIBUTOR, (B)(6), THAT THE PATIENT WAS SWITCHED TO THE MIC KEY DEVICE FROM A PEG TUBE ON (B)(6) 2017. THE PATIENT HAD BEEN PREVIOUSLY USING A PEG TUBE CONNECTED TO A CONTINUOUS FEEDING PUMP. THE PATIENT ALSO HAD A TRACHEOSTOMY AND HAD COMPLAINED PREVIOUSLY OF PAIN AND BEEN TREATED WITH STOPAYNE PRIOR TO THE PROCEDURE. THE MIC KEY WAS PLACED AND INFLATED WITH 5ML WATER. THE DEVICE APPEARED FLUSH AND NORMAL, WITH NO INDICATION OF MISPLACEMENT, AND NO STEM WAS VISIBLE ON THE OUTSIDE OF THE STOMACH. THE FOLLOWING DAY, (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT'S STOMACH HAD DISTENDED AND FEEDS WERE STOPPED, AND THE PATIENT WAS ADDED TO THE THEATRE SLATE. THE FOLLOWING DAY, (B)(6) 2017, IT WAS REPORTED THAT THE PATIENT HAD DIED. PER DISCUSSION WITH DR (B)(6) ON (B)(6) 2017, X-RAYS HAD CONFIRMED THAT THE PATIENT'S GASTRIC CONTENTS HAD BEEN LEAKING SUBCUTANEOUSLY INTO THE PERITONEAL CAVITY. THE DISTRIBUTOR REPRESENTATIVE DISCUSSED WITH THE DOCTOR ENSURING CONVERSIONS BY ENDOSCOPIC GUIDANCE OR LITMUS TEST FOR PROPER VERIFICATION OF PLACEMENT. THE PATIENT'S ORIGINAL PEG HAD BEEN IN SITU FOR AROUND THREE MONTHS. CO-MORBIDITIES INCLUDED IMMUNO-COMPROMISED THROUGH

    Patient problems: Abdominal Distention; Death; Skin Tears; Unspecified Infection

    MAUDE report 6935012 ↗

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Sources and updates

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