VISIGLIDE2 G-260-2545SRecalls & reported problems
Terumo Corporation · VISIGLIDE2 Single Use Guidewire · Class 2
All models of VISIGLIDE2 (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170358234), received between Sep 2, 2022 and Aug 7, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177164 ↗MalfunctionJul 29, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50064327 ↗MalfunctionAug 23, 2023Break; Break
THE USER FACILITY REPORTED THAT THE GUIDEWIRE BROKE.THE DEVICE WAS REPORTED TO FAIL UPON INITIAL CLINICAL USE.
Patient problems: Insufficient Information
MAUDE report 17604015 ↗InjuryJul 25, 2023Break; Break
AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT THE SINGLE USE GUIDEWIRE BROKE INSIDE THE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY. A NURSE REPORTED THAT "SOMETHING WAS DIFFERENT" ON THE SCREEN AND IT APPEARED THAT THE DEVICE FRAGMENTED. THE PHYSICIAN DID NOT TRY TO RETRIEVE THE GUIDEWIRE AS IT WAS MORE OF A RISK TO TRY TO GET INTO THE LUMEN SUCCESSFULLY. THE DEVICE FRAGMENT APPEARED TO BE ABOUT AN INCH AS CONFIRMED THROUGH X-RAY. THE PROCEDURALIST NEEDED TO ABORT THE PROCEDURE AFTER AND THE PATIENT WAS TRANSFERRED TO AN INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION WAS OBTAINED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17392964 ↗MalfunctionSep 2, 2022Break; Break
THE USER FACILITY REPORTED THAT THE GUIDEWIRE BROKE INSIDE THE DUCT.
Patient problems: Insufficient Information
MAUDE report 15350036 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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