Aristotle 18-200-001Recalls & reported problems
Scientia Vascular LLC · Guidewire-Soft · 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 00818075010097), received between Feb 8, 2023 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 Conditions3
- Foreign Body In Patient1
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 A NEUROVASCULAR PROCEDURE AN ARISTOTLE 18 GUIDEWIRE WAS USED TO HELP TREAT A HIGHLY STENOIC CAROTID WITH LOTS OF HARD PLAQUE. THE PHYSICIAN WAS USING THE ARISTOTLE 18 TO BREAK THROUGH THE PLAQUE AND AFTER SEVERAL ATTEMPTS THE WIRE HAD BECOME DAMAGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319400 ↗MalfunctionFeb 10, 2026Break
DURING A NEUROVASCULAR PROCEDURE AN ARISTOTLE 18 GUIDEWIRE WAS USED IN STROKE CASE WITH WHAT WAS SAID TO BE A VERY DIFFICULT CASE DUE TO THE ANATOMICAL PRESENTATION. THE GUIDEWIRE BROKE DURING THE PROCEDURE. IT WAS NOTED THE SYSTEM MAY HAVE KINKED AND COULD BE A CONTRIBUTING FACTOR TO THE BREAK. NO INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THE DEVICE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309619 ↗InjuryJun 25, 2024Break; Break
ON 30-MAY-2024, A SCIENTIA VASCULAR WAS NOTIFIED OF A COMPLAINT ABOUT AN ARISTOTLE 18 GUIDEWIRE TIP BREAKING AND BEING LEFT IN THE PATIENT. THE COMPLAINT UNIT WAS NOT AVAILABLE FOR RETURN TO SCIENTIA VASCULAR.
Patient problems: Foreign Body In Patient
MAUDE report 19610645 ↗MalfunctionFeb 8, 2023Break; Break
ON 9TH OF JAN, 2023 SCIENTIA VASCULAR SALES REPRESENTATIVE WAS NOTIFIED THAT AN A18-200-001 GUIDEWIRE BROKE DURING A STROKE PROCEDURE AND THE BROKEN PORTION OF THE GUIDEWIRE WAS RETRIEVED. FURTHER CONVERSATION WITH THE SALES REPRESENTATIVE INDICATED THAT A SNARE WAS USED TO RETRIEVE THE BROKEN PORTION OF THE GUIDEWIRE, AND THAT THE PROCEDURE WAS SUCESSFULLY COMPLETED USING A DIFFERENT GUIDEWIRE. THERE WAS NO PATIENT INJURY. THE COMPLAINT UNIT WAS COLLECTED ON 17 JAN 2023 AND RETURNED TO SCIENTIA VASCULAR ON 19 JAN 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16330495 ↗
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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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