Aristotle 18-200-003Recalls & reported problems
Scientia Vascular LLC · Guidewire-Support · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00818075010110), received between Mar 31, 2023 and Feb 11, 2026 — classified as 1 injury, 2 malfunctions.
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 Conditions3
- 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.
MalfunctionFeb 11, 2026Break
DURING A NEUROVASCULAR PROCEDURE AN ARISTOTLE 18 GUIDEWIRE WAS USED TO HELP CLEAR A CLOT. BECAUSE OF HOW MUCH CLOT THERE WAS THE PHYSICIAN COULD NOT ACCESS THE SAGITTAL SINUS. THE CASE WAS REPORTED TO BE A 4-5 HOUR LONG CASE AND THEY NOTICED THE ARISTOTLE 18 GUIDEWIRE WAS BROKEN WHEN THEY REMOVED IT FROM THE PATIENT. THEY DID NOT PULL ANOTHER WIRE AS THE CASE WAS AS COMPLETE AS THEY COULD GET IT. IT WAS NOTED THE PATIENT WAS IN ROUGH CONDITION, BUT THIS WAS NOT DUE TO THE GUIDEWIRE BREAK. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319442 ↗MalfunctionFeb 11, 2026Break
DURING A NEUROVASCULAR PROCEDURE AN ARISTOTLE 18 GUIDEWIRE WAS USED IN AN ISCHEMIC STROKE CASE WITH SEVERE TORTUOSITY. IT WAS NOTED THAT THE GUIDEWIRE BROKE AT THE MID DISTAL SECTION WHILE INSIDE OF A CATHETER. THE GUIDEWIRE WAS RETAINED IN THE CATHETER AND THE SYSTEM WAS REMOVED FROM THE PATIENT. NO RETRIEVAL WAS REQUIRED AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319440 ↗InjuryMar 31, 2023Break; Break
ON 07 MAR 2023, SCIENTIA VASCULAR WAS NOTIFIED THAT ON (B)(6) 2023, AN ARISTOTLE 18 - 200CM SUPPORT (A18-200-003) BROKE DURING AN ISCHEMIC STROKE CASE. THE EVENT WAS DESCRIBED AS FOLLOWS: "HYPOTUBE STUCK AND DISLODGED IN THE PATIENT DURING ISCHEMIC STROKE INTERVENTION. 2ND PASS WITH COMPLETE SYSTEM WIRE STUCK AND COULD NOT BE REMOVED." THE SAMPLE WAS NOT AVAILABLE FOR RETURN TO SCIENTIA VASCULAR FOR EVALUATION.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16659736 ↗
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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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