Halyard 42697Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY G, ISO, KIT, 12FRX0.8CM · 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 10680651426977), received between Mar 2, 2018 and Mar 2, 2018 — classified as 1 malfunction.
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
- Partial Blockage1
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.
MalfunctionMar 2, 2018Partial Blockage; Break; Partial Blockage; Break
IT WAS REPORTED THAT AFTER 12-DAYS OF PLACEMENT THE CHILD WAS MOVED IN PREPARATION FOR TRANSPORT. DURING THE TRANSPORT OF THE PATIENT THE MIC-KEY DEVICE TUBE SNAPPED. THE HEALTH PROFESSIONALS TRIED TO REPLACE THE MIC-KEY TUBE BUT IT WAS IMPOSSIBLE BECAUSE THEY COULD NOT DEFLATE THE BALLOON ON THE DEVICE. THE HEALTH PROFESSIONALS TRIED TO REMOVE THE DEVICE THREE TIMES. ON THE FOURTH ATTEMPT, THEY MANAGED TO REMOVE 3.9 ML OF WATER. THE PRESENCE OF A WHITE RESIDUE WHICH WAS OBSTRUCTING THE TUB WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7310741 ↗
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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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