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Halyard 94809Recalls & reported problems

Avanos Medical, Inc. · HALYARD* MIC* Bolus G Feeding Tube, Stock# 0110-20 · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651948097), received between Jul 6, 2017 and Jul 6, 2017 — classified as 2 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Unspecified Infection2
  • Erythema1
  • Skin Irritation1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00102 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE STOMA SITE WHICH REQUIRED PRESCRIPTION ANTIBIOTICS TO RESOLVE. THIS OCCURRED IN (B)(6) 2017. THE STOMA WAS INITIALLY PLACED IN (B)(6) 2016. NO FURTHER INFORMATION PROVIDED REGARDING THIS EVENT.

    Patient problems: Unspecified Infection

    MAUDE report 6691654 ↗
  • InjuryJul 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00101 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE STOMA SITE ON (B)(6) 2017. THE PATIENT HAS BEEN PRESCRIBED A FIVE DAY COURSE OF ANTIBIOTICS. THE PATIENT IS STABLE AND AT HOME, AND IS ONLY SORE AT THE STOMA SITE. NO LEAKING HAS BEEN OBSERVED AROUND THE STOMA SITE, ONLY REDNESS AND IRRITATION. THE PATIENT CLEANS AROUND THE STOMA SITE DAILY WITH MILD SOAP AND WATER, AND PLACES GAUZE BETWEEN THE EXTERNAL BOLSTER AND STOMACH. THE STOMA WAS INITIALLY PLACED IN (B)(6) 2016. NO FURTHER INFORMATION PROVIDED REGARDING THIS EVENT.

    Patient problems: Erythema; Skin Irritation; Unspecified Infection

    MAUDE report 6691652 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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