Aristotle 24-200-003Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00818075010141), received between Apr 10, 2024 and Feb 11, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Break
DURING AN ACA THROMBECTOMY THE PHYSICIAN WAS USING AN ARISTOTLE 24 GUIDEWIRE WHEN THEY NOTICED THE WIRE UNRAVELED AND SUBSEQUENTLY REMOVED THE WIRE FROM THE PATIENT. THERE WAS NO PATIENT INJURY AS RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319461 ↗MalfunctionFeb 11, 2026Break
DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN NOTED THEY BROKE THE CORE ON TWO ARISTOTLE 24 GUIDEWIRES. DURING PROCEDURE THEY NOTICED THE WIRE WAS NOT NAVIGABLE AND PULLED THE WIRE OUT TO FIND A LIMP AREA APPROXIMATELY 3CM FROM THE DISTAL END OF THE WIRE. NO RETRIEVAL WAS NEEDED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319454 ↗MalfunctionFeb 11, 2026Break
DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN NOTED THEY BROKE THE CORE ON TWO ARISTOTLE 24 GUIDEWIRES. THE PHYSICIAN NOTICED THE WIRE WAS NOT NAVIGABLE AND PULLED THE WIRE OUT TO FIND A LIMP AREA APPROXIMATELY 3CM FROM THE DISTAL END OF THE WIRE. NO RETRIEVAL WAS NEEDED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319443 ↗InjuryApr 10, 2024Break; Break
ON 11 MAR 2024, SCIENTIA VASCULAR EMPLOYEE WAS NOTIFIED THAT A DOCTOR ATTEMPTED TO USE AN A24-200-003 LOT #023295 AND THE GUIDEWIRE BROKE DURING A FLOW DIVERSION CASE. AFTER THE GUIDEWIRE BREAK, THE PHYSICIAN SUCCESSFULLY REMOVED THE GUIDEWIRE FROM THE PATIENT BY DOING A VACLOK MECHANICAL THROMBECTOMY PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19085338 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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