NEUROSCOUT 601-414Recalls & reported problems
Cerenovus, Inc. · NEUROSCOUT 14 STEERABLE GUIDEWIRES Guidewire Dia. .014 Inch (.36mm) Usable Length 205cm 10cm Steerable Guidewire with Hydrophilic Coating Tip Flexibility Soft 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 10886704028390), received between Jun 16, 2017 and Jun 16, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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
- Unraveled Material1
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.
MalfunctionJun 16, 2017Unraveled Material; Unraveled Material
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING CEREBRAL COIL EMBOLIZATION, AS THE NEUROSCOUT GUIDEWIRE (601414/ H28087) WAS HANDED TO THE SPECIALIST, IT WAS NOTED THAT IT HAD ¿STRANDS OUT¿, AND THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE HAD BEEN STORED AS PER LABELLING INSTRUCTIONS. THERE WAS NO PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6646549 ↗
Other GUIDE, WIRE, CATHETER, NEUROVASCULATURE devices
- Synchro SELECT SSTD215STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro2 S2SPP14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall2 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 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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