Jagwire M00556530Recalls & reported problems
Boston Scientific Corporation · High Performance Guidewire · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729876212), received between Oct 26, 2017 and Dec 16, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Device Contamination with Chemical or Other Material1
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2022Break; Break
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE. DURING THE PROCEDURE, THE BLACK PART OF THE JAGWIRE WAS LODGED IN THE PANCREATIC DUCT AND THE PATIENT HAD TO GO TO GENERAL SURGERY TO SOLVE WITH THE INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15995690 ↗MalfunctionNov 25, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS INSPECTED ON AN UNKNOWN EVENT DATE. ACCORDING TO THE COMPLAINANT, UPON INSPECTION OF THE PRODUCT AT THE DISTRIBUTION SITE, IT WAS FOUND THAT THE SEAL PART WAS PEELED OFF. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT AND THIS DEVICE WAS NOT USED IN A PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 10905263 ↗MalfunctionOct 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS UNPACKED. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THERE WAS A FOREIGN OBJECT WHICH SEEMED LIKE A HAIR FOUND INSIDE THE PACKAGE OF THIS DEVICE. THERE WAS NO PROCEDURE INVOLVED AND THE DEVICE WAS NOT USED IN THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 6979274 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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