GLIDEWIRE UWR1025Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350754592), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 injury.
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
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2017Break; Break
THIS REPORT IS BEING SUBMITTED IN RESPONSE TO USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED FROM THE FDA ON SEPTEMBER 14, 2017. THE EVENT DESCRIPTION STATES THE FOLLOWING: SURGEON HAD DIFFICULTY GETTING INITIAL WIRE THROUGH THE LEFT URETERAL STRICTURE. SURGEON DID GET ACCESS WITH A SMALL WIRE AND USED THE LASER TO OPEN THE STRICTURE AND GET A LARGER WIRE IN. THE DISTAL SEGMENT OF THE SMALL WIRE WAS INADVERTENTLY BROKEN OFF WITH THE LASER. SURGEON SAW THIS AFTER STENT WAS POSITIONED. SURGEON DETERMINED IT TO BE IN THE PATIENT'S BEST INTEREST TO LEAVE THE WIRE INSIDE THE PATIENT UNTIL THE PATIENT WAS BROUGHT BACK TO REMOVE THE STENT. PATIENT HAD A STENT EXCHANGE ABOUT 2 MONTHS LATER AND THE WIRE WAS REMOVED AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 9/20/2017: IT WAS REPORTED THAT THE PATIENT CONDITION WAS STABLE. THE PATIENT HAD THE WIRE REMOVED WHEN THE STENT WAS EXCHANGED AT A LATER DATE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6915339 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page