Halyard 42725Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY G, ISO, KIT, 14FRX1.0CM · Class 2 · Implant
All models of Halyard (232)
Data updated Oct 18, 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 10680651427257), received between Nov 14, 2019 and Nov 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Markings/Labelling 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 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
Patient problems
- Inflammation1
- 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.
InjuryNov 14, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
PER ADDITIONAL INFORMATION RECEIVED 14 NOV 2019, PATIENT INFORMATION PROVIDED. THE TUBE THAT WAS ALLEGED TO BE IN THE PACKAGING WAS CH 14, 2.0CM, WITH LOT AA2331F21. THE MOTHER OF THE PATIENT TREATED THE INFLAMMATION ALONG WITH THE HOME CARE TEAM.
Patient problems: Inflammation; No Code Available
MAUDE report 9324390 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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