GLIDEWIRE UWR6035Recalls & 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 04987350754332), received between Apr 8, 2024 and Apr 8, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE INVOLVED WIRE MALFUNCTIONED. ADDITIONAL INFORMATION WAS RECEIVED ON 09 FEB 2024: THE WIRE WAS COMING APART WHILE TRYING TO GET ACCESS. THREE WIRES WERE OPENED AND ALL THREE DID THE SAME THING. FINALLY, A DIFFERENT TYPE OF WIRE WAS OPENED (DIFFERENT BRAND) AND IT HELD UP SO THEY COULD GET ACCESS. UPDATE PER COSTUMER: THE EVENT OCCURRED DURING THE BEGINNING OF THE PROCEDURE. THE CASE WAS A PERCUTANEOUS NEPHROLITHOTRIPSY- THERAPEUTIC. THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS PROLONGED DUE TO TRYING TO GET A WIRE TO WORK PROPERLY. THE SURGEON PROCEEDED WITH A DIFFERENT WIRE. THE REPORTED PROBLEM DID NOT AFFECT THE DIAGNOSTIC OR THERAPEUTIC OUTCOME OF THE PROCEDURE. THE MEDICAL INTERVENTION WAS REQUIRED. NO OTHER DEVICES WERE CONNECTED TO THE SUBJECT DEVICE WHEN THE FAILURE OCCURRED.
Patient problems: Insufficient Information
MAUDE report 19065494 ↗
Other WIRE, GUIDE, CATHETER devices
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- 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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