GLIDEWIRE UWS1038Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE · Class 2
All models of GLIDEWIRE (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350755650), received between Apr 18, 2019 and Apr 18, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2019Break; Break
THE USER FACILITY REPORTED THAT THE DOCTOR WAS USING TWO RADIFOCUS GLIDEWIRE UROLOGIC WIRES, AND THEY BROKE IN THE PATIENT. THE BROKEN PART WAS RECOVERED. THERE WAS NO PATIENT INJURY OR FATALITY.
Patient problems: No Code Available
MAUDE report 8527375 ↗InjuryApr 18, 2019Break; Break
THE USER FACILITY REPORTED THAT THE DOCTOR WAS USING TWO RADIFOCUS GLIDEWIRE UROLOGIC WIRES, AND THEY BROKE IN THE PATIENT. THE BROKEN PART WAS RECOVERED. THERE WAS NO PATIENT INJURY OR FATALITY.
Patient problems: No Code Available
MAUDE report 8527372 ↗
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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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