AXS Catalyst 6 M003IC0601320Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327012033), received between May 21, 2018 and Oct 18, 2024 — classified as 1 death, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ASPIRATION THROMBECTOMY FOR MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION, PHYSICIAN OBSERVED THAT THE MARKER BAND ON THE TIP OF SUBJECT CATHETER WAS DETACHED AND LEFT BEHIND IN THE PATIENT'S VASCULATURE. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS ADMINISTERED ASPIRIN (ASA) POST-PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20483693 ↗
• InjuryAug 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT FOLLOWING THE ASPIRATION PROCEDURE IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) THE MARKER BAND OF THE SUBJECT CATHETER GOT DETACHED INSIDE THE PATIENT. ANOTHER NON-STRYKER ASPIRATION CATHETER WAS USED TO ATTEMPT TO COLLECT THE TIP BUT WAS UNSUCCESSFUL. THE MARKER TIP MIGRATED TO THE EXTERNAL CAROTID ARTERY (ECA) BRANCH ALL THE WAY TO THE EAR. THE CURRENT CONDITION OF THE PATIENT IS NOT WELL, BUT THE PHYSICIAN STATES NO CAUSE TO THE DETACHED MARKER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20098580 ↗
• InjurySep 29, 2022Fracture; Fracture

  IT WAS REPORTED IN A MEDWATCH REPORT DURING PROCEDURE FOR A VENOUS SINUS STENT PLACEMENT FOR IDIOPATHIC INTRACRANIAL HYPERTENSION, SEVERE LEFT TRANSVERSE SINUS STENOSIS AND SEVERE RIGHT TRANSVERSE/SIGMOID SINUS STENOSIS THE DISTAL TIP OF THE SUBJECT CATHETER WAS BROKEN OFF AT THE JUNCTION OF THE RIGHT INTERNAL JUGULAR VEIN AND SIGMOID SINUS. THE FRAGMENT TRAVELED TO THE RIGHT SIDE OF THE HEART, AND EMBEDDED IN THE LEFT LUNG. THE FRAGMENT WAS NOT REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT REQUIRED AN OVERNIGHT STAY IN THE INTENSIVE CARE UNIT FOR MONITORING, IMAGING, AND A CARDIOTHORACIC SURGERY CONSULT TO PLAN FOR FOLLOW UP APPOINTMENTS WITH NEUROSURGERY FOR A SECOND SURGERY ATTEMPT AT STENTING THE VENOUS SINUS. THE PATIENT IS CURRENTLY STABLE. THE PATIENTS ANATOMY WAS DESCRIBED AS TORTIOUS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15504320 ↗
• InjuryJun 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE OF ACUTE ISCHEMIC STROKE CASE, THE PATIENT'S BLOOD VESSEL WERE SO TORTUOUS THAT IT WAS DIFFICULT TO ENTER A CATHETER TO PERFORM THROMBECTOMY AT MCA . TO PENETRATE THE BLOCKED BLOOD VESSEL, THE PHYSICIAN USED COMPETITOR PRODUCT TWICE BUT WAS NOT ABLE TO PERFORM THROMBECTOMY. THEN THE PHYSICIAN USED A MICROCATHETER (SUBJECT DEVICE) TO TREAT CEREBRAL INFARCTION. DURING THE PROCEDURE, THE DISTAL PART OF THE SUBJECT MICROCATHETER WAS CUT OFF AND THE MAKER BAND ON IT WAS PARTIALLY CUT OFF. THE CUT OFF PORTION OF THE MARKER WENT TO THE BLOCKED MCA THROMBUS SIDE OF THE PATIENT'S BLOOD VESSELS. THE PHYSICIAN COULD NOT RETRIEVE THE BROKEN PORTION OF THE MAKER AND FINISHED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11992092 ↗
• DeathJul 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR A THROMBECTOMY FOR L M1 OCCLUSION, THE TIP OF A CATHETER (SUBJECT DEVICE) BROKE INSIDE THE PATIENT¿S ANATOMY. THE PHYSICIAN USED A THROMBECTOMY DEVICE AND BALLOON CORKING TECHNIQUE TO REMOVE THE BROKEN FRAGMENT. THE PHYSICIAN WAS UNSUCCESSFUL TO REMOVE THE BROKEN FRAGMENT AND IT REMAINS INSIDE THE PATIENT¿S ANATOMY. THERE WAS SURGICAL DELAY AND IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 10273842 ↗
• MalfunctionDec 17, 2019Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE INTERMEDIATE CATHETER(SUBJECT DEVICE) WAS TORN AT THE MIDDLE SHAFT PART AND THERE WAS LEAKAGE NOTED DURING USE AS WELL. THE CATHETER WAS REMOVED FROM PATIENT'S ANATOMY AND REPLACED WITH ANOTHER CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485468 ↗
• InjuryOct 8, 2018Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE CATHETER WAS FRACTURED AND MOVED TO THE EXTERNAL CAROTID ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7943455 ↗
• MalfunctionMay 21, 2018Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, THE SUBJECT CATHETER WAS BROKEN IN HALF WHEN REMOVED FROM THE SHEATH. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531064 ↗