Halyard 42734Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY G, ISO, KIT, 14FRX2.7CM · 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 10680651427349), received between Aug 2, 2017 and Aug 2, 2017 — 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
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2017Break; Break
IT WAS REPORTED THAT THE HUB OF THE MIC-KEY DEVICE CAME APART FROM THE LUMEN. THE INTERNAL PORTION REMAINED INSIDE THE PATIENT. THE PATIENT IS PRONE TO PULLING OUT THEIR BUTTON ON A REGULAR BASIS DUE TO BEHAVIOR ISSUES. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017, THE PATIENT IS UNDER OBSERVATION BY NURSES, TO SEE IF THE PART IS PASSED VIA STOOL. THERE WAS NO SIGN OF PAIN OR DISTRESS WHEN THE NURSE PLACED ANOTHER MIC KEY DEVICE. THERE WAS NO RESISTANCE, AND ASPIRATE OF PH WAS NORMAL, WITH NO BLOOD. THE PATIENT HAS BEEN COMFORTABLE SINCE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6759521 ↗
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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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