Journey™ M001391290Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729789857), received between Nov 13, 2018 and Dec 3, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Detachment of Device or Device Component2
- Device, or device fragments remain in patient1
- Tip breakage1
Patient problems
- Device Embedded In Tissue or Plaque2
- Aneurysm1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED VIA USER FACILITY REPORT # (B)(4). THE TARGET LESION WAS LOCATED IN AN AREA OF ABDOMINAL AORTIC ANEURYSM ENDOLEAK REPAIR. A 300CM JOURNEY GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, DURING INSERTION, THE TIP OF THE WIRE BROKE OFF IN A SMALL BRANCH. THE DEVICE FRAGMENT WAS NOT RETRIEVED AND REMAINED INSIDE THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8124510 ↗InjuryNov 14, 2018Device, or device fragments remain in patient; Tip breakage; Break; Device, or device fragments remain in patient; Tip breakage; Detachment of Device or Device Component
DURING OPERATING ROOM FOR AN AAA ENDOLEAK REPAIR, GAINING ACCESS TO THE OFFENDING VESSEL WITH THE INTENTION TO COIL IT OFF, THE TIP OF A JOURNEY WIRE BROKE OFF IN A SMALL BRANCH. TIP OF WIRE REMAINED WITHOUT RETRIEVAL ABILITY.
Patient problems: Aneurysm; Vessel Or Plaque, Device Embedded In
MAUDE report 8068995 ↗InjuryNov 13, 2018Break
DURING OR FOR A AAA ENDOLEAK REPAIR, GAINING ACCESS TO THE OFFENDING VESSEL WITH THE INTENTION TO COIL IT OFF, THE TIP OF A JOURNEY WIRE BROKE OFF IN A SMALL BRANCH. TIP OF WIRE REMAINED WITHOUT RETRIEVAL ABILITY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8070926 ↗
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.
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