GLIDEWIRE EWR6025Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350755476), received between Jun 24, 2025 and Jun 24, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation
THE USER FACILITY REPORTED THAT THE PRODUCT THE TIP FRAGMENTED DURING AN ERCP PROCEDURE WHILE THE DEVICE WAS BEING MANEUVERED PAST AS TIGHT STRICTURE. THE PRODUCT WAS DISCARDED FOLLOWING THE PROCEDURE, AND THE EXACT DATE OF THE PROCEDURE WAS UNKNOWN. THE PROCEDURE TYPE WAS THERAPEUTIC. THERE WAS NO SERIOUS INJURY AND/OR AN ADVERSE EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320705 ↗InjuryJun 24, 2025Material Fragmentation; Material Fragmentation
THE USER FACILITY REPORTED THAT THE PRODUCT THE TIP FRAGMENTED DURING AN ERCP PROCEDURE WHILE THE DEVICE WAS BEING MANEUVERED PAST AS TIGHT STRICTURE. THE PRODUCT WAS DISCARDED FOLLOWING THE PROCEDURE, AND THE EXACT DATE OF THE PROCEDURE WAS UNKNOWN. THE PROCEDURE TYPE WAS THERAPEUTIC. THERE WAS NO SERIOUS INJURY AND/OR AN ADVERSE EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320704 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
- HiWire G30474Cook Incorporated · Endoscopic guidewire, gastroenterology-urology82 reports
- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 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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