GLIDEWIRE GR3501Recalls & 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 04987350773050), received between May 24, 2024 and May 24, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2024Difficult to Insert; Peeled/Delaminated; Difficult to Insert; Peeled/Delaminated
THE USER FACILITY REPORTED THAT THE PATIENT WAS UNDERGOING AN IMPLANTATION OF AN AUTOMATIC INTERNAL CARDIAC DEFIBRILLATOR. THE PROCEDURE OPERATOR REPORTED THAT ACCESS WAS CHALLENGING DUE TO SCAR TISSUE FROM A PREVIOUS DEVICE. ONCE THE AXILLARY VEIN WAS ACCESSED, PASSING THE WIRE WAS DIFFICULT BECAUSE OF THE NUMEROUS VALVES. FOR THIS REASON, BOTH A CURVED TIP AND LATER A STRAIGHT TERUMO WIRE WERE ATTEMPTED. NOTABLY, WHEN REMOVING THE STRAIGHT-TIPPED TERUMO WIRE, SOME SHEARING OF THE OUTER COATING WAS OBSERVED. HOWEVER, THE WIRE REMAINED INTACT, AND FLUOROSCOPY SHOWED NO RETAINED MATERIAL IN THE PATIENT. THE PROCEDURE OPERATOR SUGGESTED THAT THE OUTER COATING MIGHT HAVE BEEN REMOVED WHILE ENTERING OR EXITING THE ACCESS NEEDLE. THE WIRE WAS SAVED BUT WAS INADVERTENTLY DISPOSED OF AND COULD NOT BE RETURNED TO THE MANUFACTURER. NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 14 MAY 2024: THE PATIENT'S CONDITION IS CONSIDERED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397929 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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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