Aristotle 18-200-002Recalls & reported problems
Scientia Vascular LLC · Guidewire-Standard · Class 2
All models of Aristotle (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818075010103), received between Apr 4, 2024 and Jul 30, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Break
DURING A NEUROVASCULAR STROKE PROCEDURE AN ARISTOTLE 18 (A18-200-002) STARTED TO UNRAVEL AT THE TIP AND THE GUIDEWIRE FRAYED WHEN BEING REMOVED FROM THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22671058 ↗InjuryMay 30, 2025Break; Break
THE PROCEDURE STARTED AS M1 STROKE WITH CLOT MIGRATION INTO THE M2/M3. AFTER ONE PASS WITH THE TREVO TRAK 21 AND RED72 THE CLOT DID NOT COME OUT. THE PHYSICIAN WAS ATTEMPTING ANOTHER PASS WITH SAME SYSTEM AND THIS IS WHEN THE ARISTOTLE 18 GUIDEWIRE STRETCHED AND BROKE. ABOUT 1-2 INCHES OF THE GUIDEWIRE REMAINED IN THE PATIENT. THE GUIDEWIRE WAS INSIDE THE BODY APPROX 10 MINUTES FOR BOTH PASSES BEFORE ISSUE. THE PHYSICIAN TRIED TO ASPIRATE THE WIRE OUT, BUT WAS UNSUCCESSFUL.
Patient problems: Foreign Body In Patient
MAUDE report 22118221 ↗InjuryApr 4, 2024Break; Break
ON 06 MAR 2024, SCIENTIA VASCULAR EMPLOYEE WAS NOTIFIED THAT A DOCTOR AT (B)(6) MEDICAL CENTER ATTEMPTED TO USE AN A18-200-002 LOT #024321 THAT BROKE DURING THE THROMBECTOMY PROCEDURE. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE USE OF A STENT RETRIEVER. ONLY THE PROXIMAL PORTION OF THE BROKEN GUIDEWIRE WAS RETURNED FOR EVALUATION ON 14-MAR-2024. NO INTERFACING DEVICE WAS RETURNED TO SCIENTIA VASCULAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19043431 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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