GLIDEWIRE RG*GW1818SPRecalls & 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
- 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 04987350734846), received between Apr 11, 2022 and Apr 11, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Material Separation1
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.
MalfunctionApr 11, 2022Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDEWIRE DEVICE INVOLVED BROKE DURING THE PROCEDURE. THE PATIENT WAS STABLE. THE OUTCOME OF THE PROCEDURE WAS COMPLETE. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18 MAR 2022: THE PROCEDURE PERFORMED WAS A UTERINE FIBROID EMBOLIZATION. THE PATIENT DID NOT APPEAR TO HAVE CALCIFICATIONS, TORTUOSITY, OR ETC. THE TIP LOOKED AS IF IT WAS BREAKING OFF INSIDE OF THE PATIENT. WHEN THE PHYSICIAN REMOVED THE WIRE, IT CAME APART. THE PHYSICIAN PROCEEDED TO PULL THE WIRE WITH HIS HANDS. THERE WAS NO BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 22 MAR 2022: IT WAS CONFIRMED THAT THE WIRE BROKE OFF OUTSIDE THE PATIENT, AND COULD BE RETRIEVED BY HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14077950 ↗
Other Wire, guide, catheter devices
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- 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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