AXS Catalyst 5 M003IC0581150Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327012019), received between Jun 26, 2018 and Oct 15, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CATHETER (SUBJECT DEVICE) TIP WAS BROKEN OFF IN THE PATIENT. IT WAS SUCCESSFULLY REMOVED WITH A RETRIEVER. THE PROCEDURE WAS ABORTED AND DELAYED BY A WEEK DUE TO PATIENT ILLNESS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300907 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT CATHETER WAS USED DURING A NEUROVASCULAR PROCEDURE. FOLLOWING THE PROCEDURE A ANGIOGRAM WAS PERFORMED AND A BLEED WAS NOTICED. PATIENT REQUIRED A EV (EXTERNAL VENTRICULAR) DRAIN TO BE PLACED .THE PHYSICIAN USED COILS TO STOP THE BLEED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 17264313 ↗
• InjuryFeb 8, 2021Fracture; Fracture

  MEDWATCH REPORT MW5098494 RECEIVED ON 12-JAN-2021 REPORTED THAT DURING THE PROCEDURE, THE SUBJECT CATHETER TIP BROKE AND CAUSED A LOSS OF BLOOD FLOW TO BRAIN ARTERIES. THE PATIENT IS REPORTED TO HAVE PROLONGED HOSPITALIZATION, DISABILITY, PERMANENT DAMAGE AND LIFE THREATENING CONSEQUENCES DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11293457 ↗
• InjuryDec 22, 2020Infusion or Flow Problem

  TIP OF CATHETER BROKE OF DURING NEURO INTERVENTION TREATMENT CAUSING LOSS OF BLOOD FLOW TO BRAIN ARTERIES. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11064784 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLOW DIVERTER WAS INSERTED INTO THE CATHETER TO REACH THE TARGET LESION, BUT THE FLOW DIVERTER COULD NOT BE DEPLOYED DUE TO THE TORTUOSITY IN ICA (INTERNAL CAROTID ARTERY). SO THE DEVICE WAS REMOVED BUT THE DEVICE WAS PREMATURELY DEPLOYED IN THE CATHETER DURING REMOVAL. THEREFORE, THE PHYSICIAN RETRIEVED BOTH THE FLOW DIVERTER AND CATHETER TOGETHER. THEN THE SECOND ATTEMPT WAS MADE WITH A NEW FLOW DIVERTER AND A NEW CATHETER (SUBJECT DEVICE), AND IT WAS SUCCESSFUL. POST BALLOON ANGIOPLASTY WAS PERFORMED WITH BALLOON CATHETER, AND THE PATIENT WOKE UP FINE. HOWEVER, THE SAME DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS PRIOR TO DISCHARGE. UPON SCAN, IT WAS DETERMINED THAT THE PATIENT HAD EXPERIENCED MULTIPLE SMALL STROKES AND WAS NOT DOING WELL. HENCE, THE PATIENT HAD TO STAY IN THE HOSPITAL FOR MONITORING LONGER THAN ANTICIPATED DUE TO SYMPTOMS. THE PATIENT IS DISCHARGED NOW WITH SOME SYMPTOMS MAINTAIN. IN THE PHYSICIAN¿S OPINION, THE PATIENT¿S POST PROCEDURE COMPLICATION WAS CAUSALLY RELATED TO THE VESSEL MANIPULATION, AND THE VESSEL MANIPULATION WAS DUE TO THE NEED FOR REMOVAL OF THE SYSTEM (FLOW DIVERTER AND

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 9009443 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE FLOW DIVERTER WAS INSERTED INTO THE CATHETER (SUBJECT DEVICE) TO REACH THE TARGET LESION, BUT THE FLOW DIVERTER COULD NOT BE DEPLOYED DUE TO THE TORTUOSITY IN ICA (INTERNAL CAROTID ARTERY). SO THE DEVICE WAS REMOVED BUT THE DEVICE WAS PREMATURELY DEPLOYED IN THE CATHETER DURING REMOVAL. THEREFORE, THE PHYSICIAN RETRIEVED BOTH THE FLOW DIVERTER AND CATHETER TOGETHER. THEN THE SECOND ATTEMPT WAS MADE WITH A NEW FLOW DIVERTER AND A NEW CATHETER, AND IT WAS SUCCESSFUL. POST BALLOON ANGIOPLASTY WAS PERFORMED WITH BALLOON CATHETER, AND THE PATIENT WOKE UP FINE. HOWEVER, THE SAME DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT SIDED WEAKNESS PRIOR TO DISCHARGE. UPON SCAN, IT WAS DETERMINED THAT THE PATIENT HAD EXPERIENCED MULTIPLE SMALL STROKES AND WAS NOT DOING WELL. HENCE, THE PATIENT HAD TO STAY IN THE HOSPITAL FOR MONITORING LONGER THAN ANTICIPATED DUE TO SYMPTOMS. THE PATIENT IS DISCHARGED NOW WITH SOME SYMPTOMS MAINTAIN. IN THE PHYSICIAN¿S OPINION, THE PATIENT¿S POST PROCEDURE COMPLICATION WAS CAUSALLY RELATED TO THE VESSEL MANIPULATION, AND THE VESSEL MANIPULATION WAS DUE TO THE NEED FOR REMOVAL OF THE SYSTEM (FLOW DIVERTER AND

  Patient problems: Neurological Deficit/Dysfunction; Stroke/CVA

  MAUDE report 9000767 ↗
• MalfunctionOct 15, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE FOUND THE SHAFT WAS BROKEN; THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7968166 ↗
• MalfunctionAug 14, 2018Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT DISTAL ACCESS CATHETER (DAC) SHAFT WAS BROKEN. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783598 ↗
• MalfunctionJul 18, 2018Fracture; Fracture

  THE REVIEW OF THE INVESTIGATION REVEALED THAT THE DISTAL ACCESS CATHETER (SUBJECT DEVICE) SHAFT WAS BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699905 ↗
• MalfunctionJul 10, 2018Break; Break

  ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE CATHETER SHAFT WAS BROKEN. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7676372 ↗
• MalfunctionJun 26, 2018Break; Break

  DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT CATHETER SHAFT WAS BROKEN. THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7639709 ↗