GLIDEWIRE RG*GA1818SPRecalls & reported problems
Terumo Corporation · GLIDEWIRE GT Guide Wire · Class 2
All models of GLIDEWIRE (30)
Data updated Oct 18, 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 04987350734808), received between Feb 2, 2023 and Feb 2, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (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 18, 2026.
Most reported problems
Device problems
- Material Separation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2023Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE WHEN THE GLIDEWIRE INVOLVED WAS USED, IT WAS SPUN, AND THE WIRE BROKE AT THAT MOMENT. THE PATIENT WAS IN STABLE CONDITION. THE SHEATH WAS USED INSIDE A TRAILBLAZER. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS STOPPED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 18JAN2023: THE PROCEDURE PERFORMED WHEN THE ISSUE OCCURRED WAS AN ANGIOGRAM. THE ANGIOGRAM WAS PERFORMED PRIOR TO THE PROCEDURE. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THERE WAS NO TORTUOSITY NOTED IN THE PATIENT'S ANATOMY. APPROXIMATELY 300 MM OF THE DEVICE BROKE OFF. THE ISSUE RESOLVED FOR THE PATIENT BY BEING ASPIRATED ON THE TRAILBLAZER CATHETER AND REMOVED FROM THE SHEATH. THE BROKEN WIRE WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 27JAN2023: THE WIRE BROKE WHEN IT WAS INSERTED AND MANIPULATED INSIDE THE PATIENT'S BODY.
Patient problems: Foreign Body In Patient
MAUDE report 16286923 ↗InjuryFeb 2, 2023Material Separation; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED ON 14 FEB 2023: WHEN THE DOCTOR WAS MANIPULATING THE WIRE, THE WIRE FRACTURED AND BROKE OFF INSIDE OF THE PATIENT, WITHIN THE SHEATH AND TRAILBLAZER CATHETER. THIS ALLOWED THE DOCTOR TO IMMEDIATELY RETRIEVE THE WIRE BY ASPIRATING THE CATHETER. NO WIRE FRAGMENT REMAINED IN THE PATIENT POST PROCEDURE. THE GLIDEWIRE FRACTURED AND DETACHED WITHIN THE PATIENT'S SHEATH AND GUIDE CATHETER. THERE WERE NO COMPLICATIONS OCCURRED AS RESULT OF THE DEVICE. THE PATIENT'S OUTCOME WAS NO INJURY/UNAFFECTED.
Patient problems: Foreign Body In Patient
MAUDE report 16286139 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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