GLIDEWIRE GR3507Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04987350773173), received between Mar 30, 2017 and Feb 15, 2023 — classified as 1 injury, 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
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2023Break; Break
THE USER FACILITY REPORTED THAT THE WIRE WAS OPENED, HOWEVER NOT PUT INTO THE PATIENT WHEN IT WAS NOTICED THAT THE DISTAL TIP OF THE GLIDEWIRE SEEMED TO BE SEPARATED FROM THE ENGINEERING OF THE INTERNAL WIRE. THE PATIENT WAS NOT INJURED. THE WIRE WAS NOT USED IN THE CASE. THIS WAS A NEURO PROCEDURE AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 24 JAN 2023: THE SAMPLE WAS NOT CONTAMINATED BY BLOOD/BODY FLUID, INFECTIOUS AGENTS, OR ANTI-CANCER AGENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16382667 ↗InjuryMar 30, 2017Material Fragmentation; Material Fragmentation
THE USER FACILITY REPORTED COATING ON THE WIRE HAD COME OFF DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR USED THE GLIDE WIRE THROUGH A NEEDLE WHILE ATTEMPTING ACCESS IN THE SUBCLAVIAN VEIN; A PIECE OF THE COATING SHEARED OFF INTO THE PATIENT'S CHEST WALL; OBLIQUE VIEWS WERE TAKEN AND IT WAS DETERMINED THAT THE FRAGMENT IS NOT IN THE VESSEL; THE DOCTOR DECIDED TO LEAVE THE FRAGMENT IN THE PATIENT'S CHEST; THE PROCEDURE OUTCOME WAS REPORTED AS FINE; AND THE PATIENT IS DOING FINE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6446355 ↗
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 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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