AristotleRecalls & reported problems across all models

We found 12 models of Aristotle by Scientia Vascular LLC in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2020 and Sep 25, 2026 — classified as 2 deaths, 16 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Break” (61 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Aristotle problems

Aristotle models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Aristotle ACL-200-002

  Wire, Guide, Catheter
  18 reports
• Aristotle 14-200-002

  Wire, Guide, Catheter
  13 reports
• Aristotle 24-200-002

  Wire, Guide, Catheter
  2 deaths10 reports
• Aristotle 18-200-001

  Wire, Guide, Catheter
  4 reports
• Aristotle 24-200-001

  Wire, Guide, Catheter
  4 reports
• Aristotle 24-200-003

  Wire, Guide, Catheter
  4 reports
• Aristotle 18-200-002

  Wire, Guide, Catheter
  3 reports
• Aristotle 18-200-003

  Wire, Guide, Catheter
  3 reports
• Aristotle 14-200-001

  Wire, Guide, Catheter
  2 reports
• Aristotle 14-200-003

  Wire, Guide, Catheter
  1 report
• Aristotle 14-200-004

  Guide, Wire, Catheter, Neurovasculature
  1 report
• Aristotle 14-300-004

  Guide, Wire, Catheter, Neurovasculature
  1 report

Recent Aristotle adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Break

  It was reported that during an MMA embolization procedure an Aristotle 14 guidewire broke inside of a patient approximately 5-7cm from the distal tip. The guidewire broke outside of the catheter in the patient's vasculature and required aspiration to remove the broken portion of the guidewire from the patient. The physician noted there was some tortuosity, but when they switched to a synchro wire there were no issues. It was reported that the event did not have any adverse impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897779 ↗
• MalfunctionSep 25, 2026Break

  It was reported that during an MMA embolization procedure an Aristotle 14 guidewire broke inside of a patient approximately 5-7cm from the distal tip. The guidewire broke and was caught in the catheter, and surgical intervention was not required. The physician noted there was some tortuosity, but when they switched to a synchro wire there were no issues. It was reported that the event did not have any adverse impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897778 ↗
• MalfunctionSep 25, 2026Break

  It was reported that the event occurred during an aspiration thrombectomy and an Aristotle Colossus guidewire broke during the procedure. The physician noted the wire was initially difficult to pull back into the Zoom 7X catheter with moderate resistance like other times when a wire felt a little sticky, but it came back. As it was removed from the hub, there was a longer, very thin strand that looked unwound attached to the tip. The physician assumed that must have broken off on the back table when the fellow or tech was handling it, but they were not paying attention to that and were looking at the fluoro screen completing the procedure. This was a one pass, successful aspiration thrombectomy, and the wire was only inserted once, and the wire was only shaped once. The physician did not see any wire left in the patient at the end of the procedure and nothing needed to be retrieved. There was no adverse impact on the patient from the malfunctioned guidewire.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897777 ↗
• InjurySep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722633 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING A STROKE THROMBECTOMY PROCEDURE. AFTER SUCCESFULLY TRACKING THE VECTA 71 CATHETER TO THE M1 CLOT THE ARISTOTLE COLOSSUS GUIDEWIRE WAS REMOVED. THE PHYSICIAN DID NOT KNOW THE WIRE WAS FRACTURED UPON REMOVING FROM THE CATHETER AND DID NOT NOTICE THE TIP IN THE ASPIRATION CATHETER ON IMAGING. WHEN THE PHYSICIAN ASPIRATED THE CLOT THEY NOTCIED THE TIP OF THE GUIDEWIRE COLLECTED IN THE VACLOK SYRINGE. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319696 ↗
• 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 ↗
• InjuryFeb 11, 2026Break

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR PROCEDURE THE PHYSICIAN WIRED A CAROTID THAT WENT EASY, BUT SOMEWHERE HE COULD NOT ADVANCE THE MEDTRONIC SPIDER SHEATH AS IT KEPT GETTING STUCK ON SOMETHING. THE PHYSICIAN NOTED THE PENUMBRA BENCHMARK BMX WAS NOT KINKED AND AS THEY TRIED TO ADVANCE THE SHEATH OVER THE ARISTOTLE 14 GUIDEWIRE THE WIRE BROKE INTO A MAIN PIECE AND A COUPLE SMALL PIECES. THE PIECES WERE REMOVED AND THEY CHECKED NATIVE IMAGES TO VERIFY NOTHING WAS LEFT BEHIND. THERE WAS NO INJURY TO THE PATIENT. THEY OPENED A NEW ARISTOTLE 14 AND COMPLETED THE CAROTID STENTING WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319462 ↗
• 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

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE MALFUNCTIONED DURING USE AS THE WIRE WAS REMOVED THE DISTAL 1CM OF THE WIRE REMAINED IN THE Y-CONNECTOR OUTSIDE OF THE PATIENT. THE DISTAL PORTION OF THE WIRE COMPLETELY SEPARATED. THE CASE WAS COMPLETED AT THIS POINT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319455 ↗
• 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

  THE EVENT WAS DESCRIBED AS DURING A NEUROVASCULAR PROCEDURE THE PHYSICIAN NOTICED THE GUIDEWIRE WAS NOT BEHAVING IN ITS TYPICAL MANNER. UNDER FLUOROSCOPY THE PHYSICIAN NOTICED THE WIRE DID NOT LOOK NORMAL AND DECIDED TO PULL IT OUT TO INSPECT. ONCE THE WIRE WAS REMOVED AND EXAMINED ON THE BACK TABLE THEY NOTICED THE WIRE HAD SEPARATED. ALL OF THE WIRE WAS REMOVED FROM THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319453 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE MALFUNCTIONED DURING A PROCEDURE WHILE THE WIRE WAS BEING USED TO HELP PACK IN COILS DURING A PULMONARY AVM. WHEN THE WIRE WAS REMOVED FROM THE CATHETER THE FRONT END OF THE WIRE WAS DAMAGED. THE SALES REPRESENTATIVE NOTIFIED BOTH PHYSICIANS ON THE CASE AND THE WIRE WAS IMMEDIATELY TAKEN OFF THE STERILE FIELD AND PLACED IN A BIOHAZARD BAG. IMAGES WERE THEN TAKEN TO SENSURE THE PATIENT WAS NOT HARMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319452 ↗
• 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 ↗
• MalfunctionFeb 11, 2026Break

  DURING A NEUROVASCULAR PROCEDURE AN ARISTOTLE 18 GUIDEWIRE WAS USED TO HELP CLEAR A CLOT. BECAUSE OF HOW MUCH CLOT THERE WAS THE PHYSICIAN COULD NOT ACCESS THE SAGITTAL SINUS. THE CASE WAS REPORTED TO BE A 4-5 HOUR LONG CASE AND THEY NOTICED THE ARISTOTLE 18 GUIDEWIRE WAS BROKEN WHEN THEY REMOVED IT FROM THE PATIENT. THEY DID NOT PULL ANOTHER WIRE AS THE CASE WAS AS COMPLETE AS THEY COULD GET IT. IT WAS NOTED THE PATIENT WAS IN ROUGH CONDITION, BUT THIS WAS NOT DUE TO THE GUIDEWIRE BREAK. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319442 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A ZOOM 14 GUIDEWIRE WAS USED IN A STROKE PROCEDURE AND THE GUIDEWIRE BROKE INSIDE OF A CATHETER WHILE INSIDE OF THE PATIENT. THE GUIDEWIRE WAS ABLE TO BE REMOVED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319441 ↗

Other Scientia Vascular LLC products

• Plato3 models · 3 reports · 2 recalls
• Socrates2 models · 5 reports · 1 recall