GLIDEWIRE UWS5038Recalls & 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
- 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 04987350755117), received between Nov 25, 2022 and Nov 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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 Frayed1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2022Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent
TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT NUMBER MW5112757. THE EVENT DESCRIPTION STATED THAT THE PATIENT WAS IN THE OPERATING ROOM FOR A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, BILATERAL URETERONEPHROSCOPY, URETER WIRE REMOVAL AND LEFT HOLMIUM LASER LITHOTRIPSY AND LEFT DOUBLE J STENT PLACEMENT. WHEN THE 0.038 ANGLED STIFF GLIDE WIRE WAS REMOVED FROM THE PATIENT, IT WAS NOTED BY SURGEON THAT THE WIRE WAS BENT AND FRAYED. OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15866761 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
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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