ENROUTE .014" Guidewire 11686-01 (REF SR-014-GW)Recalls & reported problems
Silk Road Medical, Inc. · ENROUTE .014" Guidewire, US · Class 2
All models of ENROUTE .014" Guidewire (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10811311020543), received between Mar 4, 2025 and Apr 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
Patient problems
- Vascular Dissection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION DURING ADVANCING. THE ARTERIAL SHEATH WAS REMOVED, THE ARTERY WAS RE-ACCESSED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT EFFECT AS A RESULT OF THE INCIDENT.
Patient problems: Vascular Dissection
MAUDE report 21880380 ↗MalfunctionMar 4, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. THE PHYSICIAN ATTEMPTED TO NAVIGATE PAST THE DISSECTION WITH THE USE OF A 3RD PARTY CATHETER AND WIRE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS ABORTED.
Patient problems: Vascular Dissection
MAUDE report 21512858 ↗
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