GLIDEWIRE GS3504Recalls & 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 04987350773555), received between Sep 11, 2018 and Sep 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2018Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 10/2/18. THE PROCEDURE BEING PERFORMED WAS A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) OF RIGHT SFA (SUPERFICIAL FEMORAL ARTERY) FROM LEFT CFA (COMMON FEMORAL ARTERY). BEFORE INTERVENTION AND TO EXCHANGE WIRE THROUGH PIGTAIL CATHETER TO FACILITATE PLACEMENT OF THE CROSSOVER SHEATH THE GLIDE WIRE BROKE. THE TIP WAS REMOVED BY REMOVING THE CATHETER SINCE IT WAS STILL INSIDE.
Patient problems: No Code Available
MAUDE report 7866111 ↗
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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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