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Halyard 95638Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC-KEY* GJ Feeding Tube-16-1.7-45.0-7-10 · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956382), received between Jul 28, 2017 and Jul 28, 2017 — classified as 1 injury.

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 Code Available1

Recent adverse event reports

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

  • InjuryJul 28, 2017Break; Break

    IT WAS REPORTED THAT THE JUNCTION WHERE THE GASTRO-JEJUNAL TUBE CONNECTED WITH THE EXTERNAL CONNECTOR BROKE WITHIN THREE MONTHS OF USE. THE FEEDING TUBE WAS CHANGED. PER ADDITIONAL INFORMATION RECEIVED ON 4 JUL 2017 THAT BECAUSE OF THE BREAK, THE PATIENT REQUIRED AN OVERNIGHT STAY IN A HOSPITAL AND AN IV. PER ADDITIONAL INFORMATION RECEIVED ON 6 JUL 2017, THE BREAK WAS INTERNAL ON THE TUBE, AND NO BROKEN PIECES WERE INSIDE THE PATIENT. THE IV WAS GIVEN TO THE PATIENT AS NO FEEDING COULD BE DONE UNTIL THE FEEDING TUBE COULD BE EXCHANGED. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Patient problems: No Code Available

    MAUDE report 6749988 ↗

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Sources and updates

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