Aristotle 14-300-004Recalls & reported problems
Scientia Vascular LLC · Guidewire 300cm Extra Support · Class 2
All models of Aristotle (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00818075010264), received between Feb 11, 2026 and Feb 11, 2026 — classified as 1 injury.
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 16, 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.
InjuryFeb 11, 2026Break
IT WAS REPORTED THAT A ZOOM 14 GUIDEWIRE FRACTURED DURING A PROCEDURE. IT WAS NOTED THERE WAS A VESSEL DISSECTION OF THE CAROTID DURING THE PROCEDURE AND WAS TREATED WITHOUT COMPLICATION. IT WAS NOTED THAT A VESSEL DISSECTION OCCURRED IN THE CAROTID BUT THE DOCTOR COULD NOT CONFIRM IT WAS CAUSED BY THE GUIDEWIRE. THE DOCTOR WAS USING THE GUIDEWIRE TO PASS THE STENT AND DEPLOY A BALLOON. THE WIRE HAD A "J" SHAPE FOR THE TIP BUT IT WAS NOT WORKING AS WELL AS THE DOCTOR WANTED AND DECIDED TO REMOVE THE GUIDEWIRE. UPON REMOVAL IT WAS NOTICED THAT THE GUIDEWIRE HAD BROKEN AND THE BROKEN PIECE OF THE WIRE WAS FOUND IN THE HEMOSTASIS VALVE. THERE WAS NO INJURY TO THE PATIENT AND NO OTHER INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24319401 ↗
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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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