Aristotle 14-200-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818075010011), received between Aug 21, 2020 and Sep 25, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, 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 ↗
• InjurySep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722633 ↗
• 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

  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

  THE EVENT WAS DESCRIBED AS DURING A LEFT TANDEM OCCLUSION STROKE THE PHYSICIAN NOTED THE GUIDEWIRE WAS DAMAGED INSIDE OF THE MICROCATHETER DURING USE. THE PHYSICIAN ALSO NOTED WAS THE WIRE NOT DAMAGED DURING PREPARATION AND TIP SHAPING. NO PART OF THE GUIDEWIRE WAS LEFT INSIDE OF THE PATIENT AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319419 ↗
• MalfunctionAug 20, 2025Break; Break

  DURING A NEUROVACULAR PROCEDURE USING AN ARISTOTLE 14 (A14-200-002) GUIDEWIRE, A STUCK OR JAMMING SENSATION WAS FELT WHILE THE PHYSICIAN WAS ADVANCING THE WIRE INSIDE OF THE CAROTID ARTERY. UPON REMOVAL OF THE GUIDEWIRE A DISTAL PORTION OF THE GUIDEWIRE WAS MISSING, HOWEVER, WHEN THEY OPENED THE Y-JUNCTION THE REMAINDER OF THE GUIDEWIRE WAS FLUSHED OUT AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER GUIDEWIRE AND NO PATIENT INJURY OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855626 ↗
• MalfunctionJul 20, 2025Break; Break

  DURING A NEUROVASCULAR COILING PROCEDURE USING AN ARISTOTLE 14 (A14-200-002) GUIDEWIRE THE NITINOL SHEATH SEPARATED. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL PARTS OF THE GUIDEWIRE AS THE SEPARATED COMPONENTS REMAINED INSIDE OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552226 ↗
• InjuryNov 15, 2023Break; Break

  ON THE 10TH OF OCTOBER 2023, SCIENTIA VASCULAR WAS NOTIFIED THAT AN ARISTOTLE 14 GUIDEWIRE (CATALOG # A14-200-002 LN:022981) BROKE DURING A PROCEDURE. THE EVENT WAS DESCRIBED AS FOLLOWS: "THE GUIDEWIRE GOT STUCK. PHYSICIAN CONTINUED TO TORQUE THE DEVICE, COULD NOT GET THE GUIDEWIRE OUT, GUIDEWIRE ENDED UP BREAKING INSIDE THE PATIENT, HOWEVER THE DOCTOR WAS ABLE TO USE A SNARE TO REMOVE THE GUIDEWIRE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141750 ↗
• InjuryJul 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, SCIENTIA VASCULAR PERSONNEL WAS NOTIFIED THAT A DOCTOR WAS USING AN ARISTOTLE 14 GUIDEWIRE (A14-200-002 LN:021236) DURING A NEUROVASCULAR PROCEDURE WHEN A VESSEL WAS DISSECTED, AND NEEDED INTERVENTION. THE EVENT WAS DESCRIBED AS FOLLOWS: "MMA CASE THE TIP OF THE WIRE SEEMED TO HAVE A SHARP EDGE TO IT AND WOULD NOT SHAPE NORMALLY. THE PRODUCT RESULTED IN A VESSEL DISSECTION. THE PHYSICIAN WAS FORTUNATELY ABLE TO COIL OFF THE VESSEL, IT WAS THE EXTRACRANIAL / SKULL BASE REGION OF THE MMA. THE PATIENT IS DOING WELL." THE GUIDEWIRE WAS RETURNED TO SCIENTIA VASCULAR FOR EVALUATION ON (B)(6) 2023. NO INFORMATION WAS PROVIDED REGARDING THE OTHER PRODUCT USED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421534 ↗
• MalfunctionDec 14, 2022Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON (B)(6) 2022, SCIENTIA VASCULAR RECEIVED A CUSTOMER COMPLAINT FOR THE ARISTOTLE A14-200-002 GUIDEWIRE. PER THE COMPLAINT DESCRIPTION "WHEN THE PHYSICIAN WAS PASSING THE CATHETER OVER THE WIRE AS HE WAS REMOVING IT, IT STRETCHED AND BROKE. THE WIRE WAS LEFT IN THE PATIENT, BUT NO PATIENT INJURY OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978706 ↗
• MalfunctionAug 31, 2020Break; Break

  FROM COMPLAINANT, "LAST WEEK WE HAD A DISTAL PCA ANEURYSM WE WERE USING AN ARISTOTLE WIRE AND IT FRACTURED ABOUT 8 INCHES FROM THE TIP. HAVE YOU SEEN THIS OR HAS IT BEEN REPORTED?- THANKFULLY WE WERE ABLE TO SLOWLY WITHDRAW THE MICROCATHETER AND GET THE WIRE OUT. I AM NOT SURE IF (B)(6) SAVED IT. IT SEEMED TO HAVE BROKEN WITH ONE LONG MICROFILAMENT THAT WENT DOWN THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10474526 ↗
• MalfunctionAug 21, 2020Break; Break

  THE DOCTOR WAS USING THE ARISTOTLE GUIDEWIRE WITH A SCEPTER XC BALLOON CATHETER INSIDE A BENCHMARK GUIDE CATHETER. HE STATED HE WAS GOING THROUGH THE PCA TO AN AVM. THE DOCTOR OBSERVED SIGNIFICANT TORTUOSITY IN THE VERTEBRAL SYSTEM AND STATED HE FELT TENSION ADVANCING THE GUIDEWIRE FORWARD. THE DOCTOR SAID HE OBSERVED THE DISTAL END OF GUIDEWIRE WAS NOT RESPONDING DURING THE PROCEDURE SO HE REMOVED THE GUIDEWIRE FROM THE PATIENT TO RESHAPE THE TIP. AFTER HE REMOVED THE GUIDEWIRE FROM THE PATIENT, HE OBSERVED THE DISTAL END OF THE GUIDEWIRE WAS STILL IN THE PATIENT; WITH THE VERY DISTAL TIP OF THE GUIDEWIRE BEYOND THE DISTAL END OF THE SCEPTER XC CATHETER. HE THEN ATTACHED A SYRINGE TO THE CATHETER AND APPLIED ASPIRATION. HE WAS THEN ABLE TO QUICKLY REMOVE THE SCEPTER XC CATHETER AND THE REMAINING DISTAL END OF THE GUIDEWIRE. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY PERFORMED WITH DIFFERENT DEVICES. BOTH SECTIONS OF THE ARISTOTLE GUIDEWIRE WERE RETAINED AND SENT TO SCIENTIA VASCULAR FOR TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10440307 ↗