Aristotle 14-200-001Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00818075010004), received between Feb 2, 2024 and Jul 17, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Break; Break
DURING A PERIPHERAL CASE WHERE AN ARISTOTLE 14 (A14-200-001) GUIDEWIRE WAS BEING USED THE TIP OF THE GUIDEWIRE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22537499 ↗InjuryFeb 2, 2024Break; Break
ON (B)(6) 2024, SCIENTIA VASCULAR PERSONNEL WERE NOTIFIED THAT AN A14-200-001 (LOT #:023431) GUIDEWIRE BROKE DURING THE PROCEDURE AT (B)(6) HOSPITAL. A FOLLOW-UP CONVERSATION WITH THE SALES REPRESENTATIVE INDICATED THAT THE PHYSICIAN USED A SNARE TO RETRIEVE THE BROKEN DISTAL PORTION OF THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18636098 ↗
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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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