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Halyard 95484Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC* TJ/GJ Feeding Tubes-18-45.0 · Class 2 · Implant

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 10680651954845), received between Sep 28, 2018 and Sep 28, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Migration1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 28, 2018Migration; Migration

    IT WAS REPORTED THAT THE TUBE, WHICH WAS PLACED ON (B)(6) 2017, MIGRATED OUT OF THE PATIENT'S MOUTH ON (B)(6) 2017. THE PATIENT REPORTED THAT THE TUBE CAME OUT OF HER MOUTH, AND SHE PUSHED IT BACK DOWN WHERE IT COILED IN HER STOMACH. THE PATIENT WAS NOT INJURED. A NEW TUBE WAS PLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7920490 ↗

Other TUBE, GASTRO-ENTEROSTOMY devices

All TUBE, GASTRO-ENTEROSTOMY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.