GLIDEWIRE GR3535Recalls & reported problems
Terumo Corporation · RADIFOCUS GLIDEWIRE · Class 2
- 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 04987350726421), received between Jan 19, 2021 and Jan 19, 2021 — 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. How this data works · Data updated Oct 13, 2026.
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.
InjuryJan 19, 2021Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS WAS USED DURING THE PROCEDURE. PART OF THE WIRE BROKE OFF IN THE PATIENT DURING THE PROCEDURE. THEY HAD TO BRING THE PATIENT BACK THE NEXT DAY TO REMOVE THE BROKEN PIECE. ADDITIONAL INFORMATION WAS RECEIVED ON 06JAN2021. THE PROCEDURE WAS A LEFT UPPER EXTREMITY VENOGRAM. ANGLE GLIDE WIRE 0.035 EXTRAVASATED OUTSIDE THE VEIN WITH PERSISTENT TWISTING OF THE WIRE; THE WIRE BECAME CAUGHT AN EXTRA VASCULAR TISSUE AS THE USER TRIED TO PULL THE WIRE THE TIP OF IT SEVERED OFF. THE USER DOES NOT BELIEVE THERE WAS ANY ISSUE WITH THE WIRE ITSELF.
Patient problems: Foreign Body In Patient
MAUDE report 11193473 ↗InjuryJan 19, 2021Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS WAS USED DURING THE PROCEDURE. PART OF THE WIRE BROKE OFF IN THE PATIENT DURING THE PROCEDURE. THEY HAD TO BRING THE PATIENT BACK THE NEXT DAY TO REMOVE THE BROKEN PIECE. ADDITIONAL INFORMATION WAS RECEIVED ON 06JAN2021. THE PROCEDURE WAS A LEFT UPPER EXTREMITY VENOGRAM. ANGLE GLIDE WIRE 0.035 EXTRAVASATED OUTSIDE THE VEIN WITH PERSISTENT TWISTING OF THE WIRE; THE WIRE BECAME CAUGHT AN EXTRA VASCULAR TISSUE AS THE USER TRIED TO PULL THE WIRE THE TIP OF IT SEVERED OFF. THE USER DOES NOT BELIEVE THERE WAS ANY ISSUE WITH THE WIRE ITSELF.
Patient problems: Foreign Body In Patient
MAUDE report 11193469 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.