GLIDEWIRE ADVANTAGE TRACK GAT1418Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE ADVANTAGE TRACK Guide wire · Class 2
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 04987350727862), received between Apr 22, 2025 and Apr 22, 2025 — 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.
Reports received per month
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.
InjuryApr 22, 2025Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THEY HAD A DEEP VEIN THROMBOSIS (DVT) PROCEDURE. THEY ATTEMPTED TO CROSS THE CAP OF THE LESION HOWEVER, THE WIRE GOT STUCK IN THE WEBBING AND BROKE OFF IN THE PATIENT. THE WIRE IS IN A STABLE POSITION AND WILL NOT NEED TO BE REMOVED. THERE WAS NO BLOOD LOSS ADDITIONAL INFORMATION WAS RECEIVED ON 26MAR2025: THE BROKEN PIECE OF THE WIRE IS APPROXIMATELY 1-3CM LONG. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. THEY DO NOT WANT TO TRY REMOVING THAT PART OF THE WIRE SINCE IT'S IN A SAFE, FIBROTIC LOCATION.
Patient problems: Foreign Body In Patient
MAUDE report 21885032 ↗InjuryApr 22, 2025Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THEY HAD A DEEP VEIN THROMBOSIS (DVT) PROCEDURE. THEY ATTEMPTED TO CROSS THE CAP OF THE LESION HOWEVER, THE WIRE GOT STUCK IN THE WEBBING AND BROKE OFF IN THE PATIENT. THE WIRE IS IN A STABLE POSITION AND WILL NOT NEED TO BE REMOVED. THERE WAS NO BLOOD LOSS ADDITIONAL INFORMATION WAS RECEIVED ON 26MAR2025: THE BROKEN PIECE OF THE WIRE IS APPROXIMATELY 1-3CM LONG. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. THEY DO NOT WANT TO TRY REMOVING THAT PART OF THE WIRE SINCE IT'S IN A SAFE, FIBROTIC LOCATION.
Patient problems: Foreign Body In Patient
MAUDE report 21885031 ↗
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- 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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