Aristotle 14-200-004Recalls & reported problems
Scientia Vascular LLC · Guidewire 200cm Extra Support · Class 2
All models of Aristotle (12)
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 00818075010240), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Break; Break
DURING A VENOUS MANOMETRY CASE THE PHYSICIAN WAS USING A ZOOM WIRE 14 X-SUPPORT GUIDEWIRE (Z14-200-004) WHEN THE WIRE GOT STICKY AND SOME "BLUE" STUFF WAS COMING OFF ON THE PHYSICIANS FINGERS. ONE OF THE STAFF THOUGHT THE WIRE HAD SHEARED. THE PATIENT WAS SAID TO BE FINE AND THE CASE WAS FINISHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23611413 ↗
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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