VISIGLIDE G-240-3527SRecalls & reported problems
Terumo Corporation · VISIGLIDE Single Use Guidewire · Class 2
Data updated Oct 16, 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 04953170282829), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pancreatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ARTICLE WAS PUBLISHED IN AN AMERICAN SCHOLARLY JOURNAL (PLOSONE). IT WAS ABOUT A RETROSPECTIVE ANALYSIS OF A TOTAL OF 85 PATIENTS WHO UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND ENDOSCOPIC ULTRASOUND (EUS) FOR SUSPECTED BILIARY STENOSIS AT THE SAMSUNG MEDICAL CENTER IN SOUTH KOREA. IN THAT ARTICLE, IT WAS REPORTED THAT THERE WAS POST-PROCEDURE ACUTE PANCREATITIS AS ADVERSE EVENTS. SINCE VISIGLIDE WAS INCLUDED IN THE DEVICE USED, IT WAS TAKEN UP AS COMPLIMENTS BY OUR US SUBSIDIARY. HOWEVER, THERE WAS NO MENTION OF THE RELATIONSHIP BETWEEN ADVERSE EVENTS AND VISIGLIDE, AND THERE WAS NO REPORT OF DEVICE MALFUNCTION.
Patient problems: Pancreatitis
MAUDE report 13001149 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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