NEUROSCOUT 601-315Recalls & reported problems
Cerenovus, Inc. · NEUROSCOUT 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 300cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Standard XL Contents: 1 guidewire, 1 torquing device and 1 introducer. · Class 2
Data updated Oct 18, 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 10886704028383), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (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
- Physical Resistance1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2017Physical Resistance; Physical Resistance
AS REPORTED BY A HEALTHCARE PROFESSIONAL, A NEUROSCOUT WIRE (601315/ H02189) GOT STUCK IN THE PROWLER SELECT PLUS MICROCATHETER LPES (606S155FX/ 17458599) AND BOTH DEVICES WERE EXCHANGED RESULTING IN LOSS OF TARGET POSITION. THE EVENT OCCURRED DURING AN ANTERIOR COMMUNICATING ARTERY PROCEDURE. NEITHER OF THE DEVICES APPEARED DAMAGED. THERE WAS NO REPORT OF PATIENT INJURY OF PROCEDURE DELAY AND IT WAS REPORTED THAT THE DEVICES WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6710201 ↗
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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