Aristotle ACL-200-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00818075010691), received between Apr 28, 2023 and Sep 25, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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

  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

  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

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE MALFUNCTIONED DURING A PROCEDURE AS THE PHYSICIAN WAS PULLING THE WIRE BACK INTO THE CATHETER AND THE WIRE SEPARATED. THERE WAS NO INJURY TO THE PATIENT AND THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319418 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE MALFUNCTIONED DURING A PROCEDURE AND THERE WAS NO DIFFICULTY ADVANCING OR REMOVING THE UNWOUND COLOSSUS. AFTER THE GUIDEWIRE WAS REMOVED THE DISTAL TIP WAS NOTED TO BE FRACTURED AND HANGING BY A THREAD. NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319416 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE STRETCHED OUT DURING A PROCEDURE. THE PHYSICIAN STATED THE WIRE WAS NOT AT FAULT AND THE TORTUOSITY OF THE PATIENT AFFECTED THE SYSTEM IN TOTAL AND MADE THE MOVEMENT OF THE WIRE VERY TIGHT WHEN PULLING IT BACK. THE PATIENT WAS NOT HARMED AND THE WIRE WAS REMOVED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319415 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A ARISTOTLE COLOSSUS GUIDEWIRE MALFUNCTIONED DURING A BASILAR ANEURYSM PROCEDURE. THE GUIDEWIRE WAS SAID TO HAVE UNRAVELED OR DELAMINATED AS IT WAS BEING PULLED OUT OF THE PATIENT. THE BROKEN PIECE REMAINED IN THE RHV AND CATHETER JUNCTION. THE PHYSICIAN INDICATED THAT THE FELLOW CLOSED THE RHV TIGHT WHICH PINCHED THE CATHETER THUS PINCHING THE COLOSSUS GUIDEWIRE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319399 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE IT WAS REPORTED THAT AN ARISTOTLE COLOSSUS GUIDEWIRE FRACTURED INSIDE OF A CATHETER DURING A CEREBRAL ANGIOGRAM WITH THROMBECTOMY PROCEDURE. ALL OF THE WIRE WAS RETRIEVED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309624 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE A ARISTOTLE COLOSSUS GUIDEWIRE (ACL-200-002) WAS PULLED OUT OT THE HOOP AND HYDRATED IN A BOWL OL HEPARINIZED SALINE DURING PROCEDURE. THE PHSYICIANS GOT ACCESS TO BOTH FEMORAL ARTERY AND VEIN FOR VENOUS SINUS PRESSURE MEASUREMENTS. THEY SHAPED THE WIRE TO DESIRED EFFECT AND TRACKED THE WIRE AND BOTH TH6 4F GLIDE CATHETER, THEN THE 5F ENVOY TO DESIRED POSITIONS. THE 4F ANGLED GLIDE CATHETER WAS PLACED JUST PAST THE ICA ORGIN. THE 5F ENVOY WAS TRACKED THROUGH THE VENOUS SYSTEM AND ENDED UP BEING PLACED AT THE TORQULA. WHEN TRACKING THROUGH THE VENOUS SINUSES THE OPERATOR NEEDED A BIT OF A DILLERENT SHAPE, HE PULLED THE WIRE, RESHAPED IT AND ENDED UP BEING ABLE TO ADVANCE THE WIRE THROUGH THE SAGITTAL SINUS AND THE CATHETER TO ITS RESTING POSTITION IN THE TRANSVERSE SINUS IUST PROXIMAL TO THE TORCULA. THEY TOOK THE WIRE OUT AND THEN PLACED A MARKSMAN CATHETER AND AN A24-200-002 TO FINISH THE PROCEDURE AND TAKING PRESSURES. AFTER LOOKING AT THE ACL AT THE END OF THE CASE, THE OPERATOR NOTICED IT LOOKED LIKE THE WIRE GOT A BIT STRETCHED IN THE SHAPING SECTION OF THE WIRE. HE ASKED IF WE COULD TAKE IT BACK AND LOOK AT IT JUST TO ENSURE NOTHING IS WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309564 ↗
• MalfunctionFeb 10, 2026Break

  DURING A NEUROVASCULAR PROCEDURE IT WAS REPORTED THAT THE NITINOL HYPOTUBE OF AN ARISTOTLE COLOSSUS GUIDEWIRE MAY HAVE KINKED DURING THE STROKE PROCEDURE AND BECAME STRETCHED. IT WAS NOTED THE WIRE WAS USED WITH MANY DIFFERENT CATHETER THROUGHOUT THE PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309562 ↗
• InjuryJul 9, 2025Break; Break

  DURING A STROKE PROCEDURE THE PHYSICIAN WAS USING AN ARISTOTLE COLOSSUS ACL-200-002 WHEN THE WIRE BECAME UNWOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22462081 ↗
• MalfunctionJul 9, 2025Break; Break

  DURING A NEUROVASCULAR PROCEDURE THE WIRE STRETCHED WHILE THE DOCTOR WAS PULLING IT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461833 ↗
• MalfunctionJun 14, 2025Break; Break

  EVENT OCCURRED DURING A STROKE THROMBECTOMY. COLOSSUS SUCCESSFULLY TRACKED ZOOM 71 TO A RIGHT M1 THROMBUS. UPON REMOVAL, THE WIRE GOT SNAGGED INSIDE THE CATHETER AND THEN FRACTURED. THERE IS A SMALL FRACTURE AND UNSPOOLING IN THE DISTAL 1.5CM AND A FULL FRACTURE AROUND 10CM. THE ENTIRE WIRE WAS ABLE TO BE REMOVED FROM THE CATHETER AND THE PATIENT DID NOT RETAIN ANY OF THE WIRE. THERE WAS NO PATIENT INJURY. THE THROMBUS WAS SUCCESSFULLY REMOVED ON THE FIRST PASS AND NO RE-ACCESS WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208394 ↗
• InjuryAug 9, 2024Break; Break

  ON THE 11TH OF JUL 2024, A SCIENTIA VASCULAR EMPLOYEE WAS NOTIFIED OF A COMPLAINT ABOUT AN ARISTOTLE COLOSSUS (ACL-200-002 LN: 027057) GUIDEWIRE TIP BREAKING AFTER GETTING STUCK IN A BRANCH VESSEL. THE COMPLAINT GUIDEWIRE WAS RETURNED TO SCIENTIA VASCULAR ON THE 2ND OF AUG 2024. NO UPDATES ON PATIENT STATUS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19956370 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 13 MAY 2024, SCIENTIA VASCULAR EMPLOYEE WAS NOTIFIED THAT A DOCTOR WAS USING AN ACL-200-002 LOT #026031 DURING AN ASPIRATION THROMBECTOMY PROCEDURE, AND THE DISTAL PORTION OF THE GUIDEWIRE BROKE DURING THE CASE. THE BROKEN PORTION OF THE GUIDEWIRE WAS CAPTURED IN THE ZOOM POD ALREADY SET UP FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512875 ↗
• MalfunctionJan 31, 2024

  GUIDEWIRE BROKE INSIDE THE CATHETER. PIECES WERE RETRIEVED WITH NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613039 ↗
• InjuryApr 28, 2023Break; Break

  ON THE 31 OF MARCH 2023, SCIENTIA VASCULAR WAS NOTIFIED THAT AN ARISTOTLE COLOSSUS GUIDEWIRE (CATALOG # ACL-200-002 LN:021376) STRETCHED AND SHEARED OFF DURING A NEUROVASCULAR PROCEDURE. THE EVENT WAS DESCRIBED AS FOLLOWS: "THE COLOSSUS GUIDEWIRE STRETCHED AND THEN SHARED OFF DURING THE 2ND THROMBECTOMY ASPIRATION PASS. A PORTION OF THE GUIDEWIRE WAS LEFT IN THE DISTAL MCA. IN TOTAL THE PHYSICIAN PERFORMED 9 PASSES DUE TO THE EXTENSIVE THROMBUS BURDEN." THE DOCTOR INFORMED THE PATIENT OF THE GUIDEWIRE FRACTURE AND MENTIONED THE PATIENT WAS DOING WELL, AND THAT THE GUIDEWIRE BREAKING DID NOT OFFER ANY ADVERSE EFFECT. THE REMAINING PORTION OF THE COMPLAINT UNIT WAS RETURNED TO SCIENTIA VASCULAR FOR EVALUATION ON (B)(4)2023.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16839604 ↗