VISIGLIDE G-240-2545ARecalls & reported problems
Terumo Corporation · VISIGLIDE Single Use Guidewire · Class 2
Data updated Oct 18, 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 04953170282805), received between Jul 19, 2022 and Jul 19, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture1
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.
InjuryJul 19, 2022Fracture; Fracture
THE USER FACILITY REPORTED THAT DURING A CHOLANGIOGRAM, UNDER ENDOSCOPIC ULTRASOUND (EUS) GUIDANCE, THE PUNCTURE WAS PERFORMED VIA THE STOMACH USING A 19 G NEEDLE. THE GUIDEWIRE WAS ADVANCED THROUGH THE LIVER IN THE JEJUNUM. TO PREVENT THE WIRE FROM CHANGING THE POSITION WHEN EXTRACTING THE CYSTOTOME, THE GUIDEWIRE WAS FIXED IN THE BILIARY SYSTEM WITH A SNARE, THEN THE CYSTOTOME WAS PULLED OUT. AS A RESULT, THE GUIDEWIRE BROKE ABOUT 20 CENTIMETERS FROM THE STARTING POINT OF THE METAL PART. THE DISTAL PART WAS REMAINED FROM THE LIVER INTO THE STOMACH. THE FRACTURED PIECE FELL OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A SNARE FROM THE STOMACH AND NO RESIDUE WAS CONFIRMED. THE FINAL PATIENT IMPACT WAS HARMED, BUT NON-SERIOUS. THE EVENT OCCURRED INTRA-OPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051151 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
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- 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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