GLIDEWIRE GR3525Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE · Class 2
Data updated Oct 13, 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 04987350707284), received between Mar 8, 2022 and Mar 8, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Cramp(s) /Muscle Spasm(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
THE SOURCE OF THIS REPORT CAME FROM A REGISTRY AND THE FOLLOWING ADVERSE EVENT WAS FOUND ON REVIEW: THE USER FACILITY REPORTED THAT THE PATIENT HAD A MILD SPASM IN THE RADIAL ARTERY UPON ADVANCEMENT OF THE 1.5 MM J WIRE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18 FEB 2022: THE PROCEDURE PERFORMED WAS A PROSTATIC ARTERY EMBOLIZATION (PAE). THERE WAS NO MEDICATION GIVEN TO THE PATIENT. THERE WERE NO OTHER PROCEDURES PERFORMED TO MITIGATE THE ISSUE. A LARGE TR BAND WAS USED AFTER THE PROCEDURE.
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 13694933 ↗InjuryMar 8, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
THE SOURCE OF THIS REPORT CAME FROM A REGISTRY AND THE FOLLOWING ADVERSE EVENT WAS FOUND ON REVIEW: THE USER FACILITY REPORTED THAT THE PATIENT HAD A MILD SPASM IN THE RADIAL ARTERY UPON ADVANCEMENT OF THE 1.5 MM J WIRE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18 FEB 2022: THE PROCEDURE PERFORMED WAS A PROSTATIC ARTERY EMBOLIZATION (PAE). THERE WAS NO MEDICATION GIVEN TO THE PATIENT. THERE WERE NO OTHER PROCEDURES PERFORMED TO MITIGATE THE ISSUE. A LARGE TR BAND WAS USED AFTER THE PROCEDURE.
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 13693131 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page