AXS Catalyst 5 M003IC0581320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327011999), received between May 4, 2018 and Sep 26, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT CATHETER BROKE OFF DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155461 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE PERFORMING A DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) PATIENT SUFFERED STROKE, A NON OCCLUSIVE THROMBUS IN THE RIGHT DISTAL ACA TERRITORY AND MCA INFERIOR DIVISION WAS NOTICED. PATIENT WAS ADMINISTERED 2 MG TPA X 2 AND 2 MG INTEGRELLIN INJECTED IN THE A3 SEGMENT, AND 2 MG OF INTEGRELLIN INJECTED IN THE INFERIOR DIVISION OF MCA M4 SEGMENT WITH IMPROVEMENT SEEN OF DISTAL FLOW. STUDY DEVICE WAS NOT IMPLANTED DUE TO TREATMENT OF THE THROMBUS. IT WAS INDICATED THAT THE STROKE HAD CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE, AND HAS A POSSIBLE RELATIONSHIP WITH TO DAPT, OTHER STRYKER DEVICES (INCLUDING THE SUBJECT CATHETER) AND AN UNDERLYING CONDITION OR DISEASE. IT WAS NOTED THAT THE OUTCOME OF THE STROKE WAS RECOVERED/RESOLVED ON (B)(6) 2023. ON THE SAME DAY, POST PROCEDURE, PATIENT WAS EXTUBATED WITH CONCERN FOR NEW STROKE, TAKEN FOR CT HEAD, AT WHICH TIME SHE BECAME UNRESPONSIVE AND HYPOTENSIVE, REQUIRED INTUBATED, EMERGENT CTA ABD/PELVIS REVELING ACTIVE EXTRAVASATION FROM THE R CFA WITH ASSOCIATED HEMATOMA (RETROPERITONEAL HEMORRHAGE). PATIENT WAS TRANSFERRED EMERGENTLY TO NSICU AND VASCULAR SURGERY WAS CANCELLED. PATIENT INITIALLY REQUIRED PH

  Patient problems: Multiple Organ Dysfunction Syndrome; Retroperitoneal Hemorrhage; Stroke/CVA

  MAUDE report 16792146 ↗
• MalfunctionDec 9, 2021Fracture; Fracture

  ANALYSIS OF THE RETURNED SUBJECT DEVICE FOUND THE CATHETER SHAFT WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973406 ↗
• InjuryDec 27, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE SUBJECT DEVICE DISTAL TIP WAS CAME OFF WHEN REMOVING IT FROM THE BRAIN, AND THE SUBJECT DEVICE DISTAL TIP MOVED DOWN TO THE AORTA. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8201208 ↗
• MalfunctionJul 26, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO OPERATION WHEN OPENING THE PRODUCT, THE CATHETER SHAFT HAD A HOLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7724794 ↗
• MalfunctionMay 4, 2018Break; Break

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488661 ↗