VISIGLIDE2 G-260-2527ARecalls & reported problems
Terumo Corporation · VISIGLIDE2 Single Use Guidewire · Class 2
- 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 04953170358203), received between Jan 14, 2023 and Jan 14, 2023 — classified as 1 injury, 1 malfunction.
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
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2023Material Separation; Material Separation
THE SALES REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE FOR THE G-260-2527 A VIZIGLIDE WIRE INVOLVED. DURING THE PROCEDURE THE G-260-2527 A SNAGGED THE ELEVATOR OF THE T JF-Q 190V AND THE WIRE SNAPPED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING A SECOND G-260-2527 A WIRE. THIS WAS AN OUT OF BOX FAILURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11 JAN 2023: THE PROCEDURE PERFORMED WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO BLOOD LOSS. THE DEVICE BROKE OUTSIDE THE BODY. THE USER OF THE DEVICE WAS ABLE TO PULL THE DEVICE BACK THRU THE SCOPE WHEN IT LOOKED DAMAGED AT APPROXIMATELY 6-7CM FROM THE DISTAL TIP.
Patient problems: Insufficient Information
MAUDE report 16169852 ↗InjuryJan 14, 2023Material Separation; Material Separation
THE SALES REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE FOR THE G-260-2527 A VIZIGLIDE WIRE INVOLVED. DURING THE PROCEDURE THE G-260-2527 A SNAGGED THE ELEVATOR OF THE T JF-Q 190V AND THE WIRE SNAPPED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING A SECOND G-260-2527 A WIRE. THIS WAS AN OUT OF BOX FAILURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11 JAN 2023: THE PROCEDURE PERFORMED WAS AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO BLOOD LOSS. THE DEVICE BROKE OUTSIDE THE BODY. THE USER OF THE DEVICE WAS ABLE TO PULL THE DEVICE BACK THRU THE SCOPE WHEN IT LOOKED DAMAGED AT APPROXIMATELY 6-7CM FROM THE DISTAL TIP.
Patient problems: Insufficient Information
MAUDE report 16169849 ↗
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- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
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- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.