Jagwire™ Revolution M00557010Recalls & reported problems
Boston Scientific Corporation · High Performance Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729962410), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated1
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.
MalfunctionSep 25, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT A JAGWIRE REVOLUTION GUIDEWIRE WAS ATTEMPTED TO BE USED IN THE LEFT HEPATIC AND COMMON BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND GUIDED TRANSGASTRIC BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS BEING USED TO ATTEMPT TO CANNULATE THE LEFT HEPATIC AND COMMON BILE DUCT. HOWEVER, THE PHYSICIAN WAS UNABLE TO COMPLETE CANNULATION DUE TO SEVERE ANGULATION. WHEN THE WIRE WAS REMOVED, IT WAS OBSERVED THAT THE WIRE JACKET COATING WAS PARTIALLY STRIPPED APPROXIMATELY THREE CENTIMETERS. ANOTHER NON-BSC GUIDEWIRE DEVICE WAS ATTEMPTED TO BE USED WITHOUT SUCCESS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS REFERRED FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) BUT IT IS UNKNOWN IF THE PTC HAS BEEN COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301141 ↗
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- 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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