Aristotle 24-200-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00818075010134), received between Jul 30, 2024 and Feb 11, 2026 — classified as 2 deaths, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  IF WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE AN ARISTOTLE 24 GUIDEWIRE WAS DEFECTIVE. THERE WAS NO PATIENT INJURY AS RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319495 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE AN ARISTOTLE 24 GUIDEWIRE WAS DEFECTIVE AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319417 ↗
• MalfunctionFeb 11, 2026Break

  DURING A PROCEDURE, THE PHYSICIAN WAS USING THE GUIDEWIRE WHEN THEY NOTICED THERE WAS A FRACTURE OF THE DISTAL TIP UNDER FLUOROSCOPY AND REMOVED THE WIRE WITH NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH NO INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319398 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN WAS USING THE GUIDEWIRE AND WHEN THEY REMOVED THE WIRE FROM THE PATIENT AFTER BEING INTRACRANIAL THE WIRE WAS DAMAGED. THE GUIDEWIRE MALFUNCTION OCCURRED INSIDE OF THE PATIENT AND NO INTERVENTION WAS REQUIRED TO RETRIEVE ANY PORTION OF THE DAMAGED DEVICE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309623 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN WAS USING THE GUIDEWIRE AND IT BROKE. ALL OF THE WIRE WAS ABLE TO BE REMOVED AND ANOTHER DEVICE WAS PULLED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309621 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN WAS PUTTING THE WIRE IN AND FELT FRICTION. THE PHYSICIAN NOTICED THE DISTAL END OF THE WIRE WAS STARTING TO UNRAVEL AND SUBSEQUENTLY REMOVED THE GUIDEWIRE AND REPLACED IT WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH NO ISSUE AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309563 ↗
• MalfunctionDec 2, 2025Break; Break

  DURING A ANEURYSM CASE USING AN ARISTOTLE 24 (A24-200-002) GUIDEWIRE BY RADIAL ACCESS THE PHYSICIAN NOTED THE CATHETER KINKED AND THE GUIDEWIRE GOT CAUGHT AND STRETCHED. THE PHYSICIAN MENTIONED THE GUIDEWIRE PERFORMING WELL GOING INTO THE ICA AND THE GUIDEWIRE TIP WAS RESPONDING AS EXPECTED UP UNTIL THE GUIDEWIRE BROKE. THE PHYSICIAN ALSO MENTIONED THEY DECIDED TO PERFORM THE PROCEDURE THROUGH THE ARM / SHOULDER AND THAT IT WAS A TORTUOUS PATHWAY WITH A SHARP TURN AND WAS HARD TO NAVIGATE. THE PHYSICIAN LOST TIP CONTROL WHEN THEY WITNESSED THE CATHETER KINKING AND THE GUIDEWIRE STRETCHING. THE PHYSICIAN PULLED EVERYTHING OUT AND DECIDED TO SWITCH ACCESS TO THE GROIN INSTEAD USING A NEW ARISTOTLE 24. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699343 ↗
• InjuryFeb 20, 2025Break; Break

  WHILE TRYING TO POSITION A PHENOM 27 IN A FUSIFORM ANEURYSM THE PHYSICIAN DECIDED TO REPLACE THE SYNCHRO GUIDEWIRE WITH AN ARISTOTLE 24 GUIDEWIRE. WITHIN TWO MINUTES OF USING THE ARISTOTLE 24 GUIDEWIRE THE PHYSICIAN REMOVED THE WIRE TO RESHAPE THE TIP. WHEN HE REMOVED THE WIRE APPROXIMATELY 1.5 INCHES TO 2 INCHES OF THE DISTAL PORTION OF THE GUIDEWIRE BROKE OFF AND REMAINED INSIDE OF THE ANEURYSM. THE BROKEN PORTION OF THE GUIDEWIRE WAS THEN ENCAPSULATED INSIDE OF THE ANEURYSM WITH THE FLOW DIVERTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 21421574 ↗
• DeathAug 20, 2024Break; Break

  ON 22 JUL 2024, SCIENTIA VASCULAR WAS NOTIFIED THAT AN A24-200-002 GUIDEWIRE FRACTURED DURING A NEUROVASCULAR PROCEDURE, ATTEMPTS TO GATHER MORE INFORMATION BETWEEN THE SCIENTIA VASCULAR SALES REPRESENTATIVE AND THE HOSPITAL OCCUR, AND NO ADDITIONAL INFORMATION WAS PROVIDED. ON 26 JUL 2024, DETAILS OF THE EVENT WERE PROVIDED TO SCIENTIA VASCULAR. THE EVENT WAS DESCRIBED AS FOLLOWS: "DURING MECHANICAL THROMBECTOMY FOR ACUTE STROKE, THE DISTAL TIP OF THE REPERFUSION CATHETER TIP SEPARATED. AFTER SUCCESSFUL RECANALIZATION, IT APPEARED THAT THE CATHETER TIP WAS RETAINED IN THE THROMBOSIS AND ULTIMATELY MIGRATED; RESULTED IN M1 OCCLUSION. AN ARISTOTLE 24 GUIDEWIRE WAS USED TO TRY TO OBTAIN THE BROKEN CATHETER TIP, THE GUIDEWIRE ALSO FRACTURED AND CONTRIBUTED TO THE OCCLUSION. OCCLUSION COULD NOT BE CLEARED. MANY ATTEMPTS TO RETRIEVE CATHETER TIP AND GUIDEWIRE WITH A VARIETY OF STRATEGIES WERE UNSUCCESSFUL." THE COMPLAINT GUIDEWIRE WAS NOT RETURNED TO SCIENTIA VASCULAR FOR EVALUATION, DESPITE SALES REPRESENTATIVE ATTEMPTS TO COLLECT THE GUIDEWIRE.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 20005961 ↗
• DeathJul 30, 2024

  DURING MECHANICAL THROMBECTOMY FOR ACUTE STROKE, THE DISTAL TIP OF THE REPERFUSION CATHETER TIP SEPARATED. AFTER SUCCESSFUL RECANALIZATION, IT APPEARED THAT THE CATHETER TIP WAS RETAINED IN THE THROMBOSIS AND ULTIMATELY MIGRATED; RESULTED IN M1 OCCLUSION. AN ARISTOTLE 24 GUIDEWIRE WAS USED TO TRY TO OBTAIN THE BROKEN CATHETER TIP, THE GUIDEWIRE ALSO FRACTURED AND CONTRIBUTED TO THE OCCLUSION. OCCLUSION COULD NOT BE CLEARED. MANY ATTEMPTS TO RETRIEVE CATHETER TIP AND GUIDEWIRE WITH A VARIETY OF STRATEGIES WERE UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 19876094 ↗