Halyard 44295Recalls & reported problems
Avanos Medical, Inc. · HYH-MIC,GTUBE,ENFIT-FTUB,-,22FR,1 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651442953), received between Jan 11, 2019 and Jan 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Bruise/Contusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2019Use of Device Problem; Use of Device Problem
AN FDA MEDWATCH MW5082361 WAS RECEIVED 01-FEB-2019. ADDITIONAL INFORMATION RECEIVED 01-FEB-2019 STATING, "WE ENCOUNTERED A TUBE (ENFIT 20F) THAT WAS DELIVERED WITH THE BUMPER ON THE TUBE UPSIDE DOWN. UNFORTUNATELY THE PLACEMENT TEAM DID NOT CATCH THIS AND PLACED THE TUBE CAUSING STOMA SITE HARM TO THE PT [PATIENT]. WE REPORTED THIS INTERNALLY FROM OUR OWN REVIEWS.
Patient problems: Bruise/Contusion
MAUDE report 8239337 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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