JUDO™ 3 H749393773000Recalls & reported problems
Boston Scientific Corporation · 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 08714729974963), received between May 11, 2021 and May 11, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2021Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
IT WAS REPORTED VIA MEDWATCH (B)(4) THAT A GUIDEWIRE BREAK OCCURRED AND A DEVICE FRAGMENT REMAINED IN THE PATIENT. THE PATIENT PRESENTED WITH A CALCIFIED 100% OSTIAL LESION IN THE LEFT SUBCLAVIAN AND TUBULAR 50% OSTIAL LESION IN THE RIGHT SUBCLAVIAN. THE PATIENT UNDERWENT A PERIPHERAL ANGIOGRAPHY. THE JUDO GUIDEWIRE WAS INTRODUCED BUT WAS UNABLE TO CROSS THE LEFT SUBCLAVIAN OCCLUSION BOTH RETROGRADE AND ANTEGRADE. PART OF THE DEVICE BROKE OFF AND ENDED UP IN A SUBINTIMAL PLANE WITH NO RISK OF EMBOLIZATION.
Patient problems: Foreign Body In Patient
MAUDE report 11809831 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page