GLIDEWIRE RG*GW1618SPRecalls & 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 04987350734280), received between Jun 14, 2019 and Jun 14, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2019Difficult to Advance; Difficult to Advance
THE USER FACILITY REPORTED THAT THE PHYSICIAN HAD A 4FR GLIDECATH AND PROGREAT 2.4 TRACKED OUT TO THE ANEURYSM; THIS WAS A TYPE II ENDOLEAK. HE WAS USING THE .016 DOUBLE ANGLE GT IN THE BEGINNING OF THE CASE; HOWEVER, MADE A COMMENT THAT IT WAS TOO STICKY, HE SWITCHED OUT FOR A COMPETITORS, AND WHEN HE EXCHANGED BACK FOR THE .016 GT HE SAID HE WAS HAVING A HARD TIME TRACKING IT THROUGH THE PROGREAT. HE COULD NOT TORQUE IT BECAUSE IT WAS SO STICKY. HE OPENED ANOTHER ONE AND IT WORKED FINE. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS REPORTED TO BE IN GOOD AND STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 12, 2019. THE PROCEDURE OUTCOME WAS SUCCESSFUL.
Patient problems: Blood Loss
MAUDE report 8700718 ↗
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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