Halyard 42700Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY G, ISO, KIT, 12FRX1.5CM · 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 10680651427004), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
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.
MalfunctionFeb 26, 2020Material Separation; Material Separation
IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE FEEDING TUBE "CAME OUT WITHOUT THE BALLOON." THE TUBE WAS NOT FULLY INTACT; THE BALLOON HAD SEPARATED FROM THE TUBE. TUBE WAS INSERTED ON (B)(6) 2020. PATIENT WENT TO THE HOSPITAL FOR REPLACEMENT. NO PATIENT INJURY WAS REPORTED. THE PATIENT'S MOTHER REPORTS THAT THE HOSPITAL SAID THAT THE BALLOON WOULD PASS NATURALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9756678 ↗
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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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