VISIGLIDE2 G-260-3545ARecalls & reported problems
Terumo Corporation · VISIGLIDE2 Single Use Guidewire · Class 2
All models of VISIGLIDE2 (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170358265), received between Apr 3, 2018 and Jan 10, 2023 — classified as 1 injury, 2 malfunctions.
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
- Component Missing1
- Fracture1
- Material Frayed1
- Peeled/Delaminated1
Patient problems
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2023Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT THE GUIDE WIRE HAS ABOUT 2 TO 3 CM THE METAL IS NOT COVERED.
Patient problems: Insufficient Information
MAUDE report 16128643 ↗MalfunctionSep 16, 2022Fracture; Component Missing; Fracture; Component Missing
THE USER FACILITY REPORTED THAT DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE DOCTOR OPENED AN ANGLE PACKAGE VISIGLIDE; HOWEVER, IT WAS STRAIGHT. THE DISTAL TIP WAS MISSING, IT IS NOT BELIEVED TO HAVE FALLEN IN THE PATIENT. THE DOCTOR NOTICED THE ISSUE WHILE THE UNIT WAS BEING INSERTED INTO THE SCOPE.
Patient problems: Insufficient Information
MAUDE report 15438396 ↗InjuryApr 3, 2018Break; Material Frayed; Break; Material Frayed
THE USER FACILITY REPORTED A FRAY AND THE TIP BROKE OFF IN THE LIVER. THE NEEDLE WAS WITHDRAWN AND PROCEDURE ABORTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PROCEDURE OUTCOME AND THE PATIENT'S CONDITION IS UNKNOWN.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7393259 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
- HiWire G30474Cook Incorporated · Endoscopic guidewire, gastroenterology-urology82 reports
- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 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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