AXS Catalyst 7 IC068132Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327417227), received between Dec 17, 2019 and Mar 6, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE CATHETER (SUBJECT DEVICE) WAS BROKEN/FRACTURED 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 18853005 ↗
• MalfunctionNov 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROXIMAL SHAFT OF THE SUBJECT CATHETER WAS KINKED AND THEN EVENTUALLY BROKE NEAR THE HUB. THERE WAS SURGICAL DELAY OF 5 MINUTES REPORTED. THE SUBJECT CATHETER WAS REPLACED, AND 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 18089825 ↗
• MalfunctionMay 24, 2022Fracture; Fracture

  THE SUBJECT ASPIRATION CATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED 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 14490664 ↗
• MalfunctionMay 24, 2022Fracture; Fracture

  THE SUBJECT ASPIRATION CATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED 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 14490655 ↗
• MalfunctionMar 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER ASPIRATION, WHEN THE PHYSICIAN REMOVED THE SUBJECT CATHETER FROM THE PATIENT'S ANATOMY, THE PROXIMAL PART OF THE SUBJECT CATHETER WAS FOUND BROKEN. THE PHYSICIAN REMOVED THE FRACTURED FRAGMENT OF THE SUBJECT CATHETER OUT OF THE PATIENT'S ANATOMY. 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 13684510 ↗
• MalfunctionJun 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER (SUBJECT DEVICE) SHAFT WAS KINKED AND BROKEN NEAR THE HUB. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076934 ↗
• MalfunctionJun 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER (SUBJECT DEVICE) WAS USED TO ACCESS FEMORAL ARTERY SITE, WHEN INSERTING THE CATHETER (SUBJECT DEVICE) INTO THE LONG SHEATHS, THE RESISTANCE ENCOUNTERED AS THE CATHETER (SUBJECT DEVICE) PASSED AREA AT END OF THEIR LONG SHEATHS AND THE CATHETER SHAFT WAS NOTICED TO BE FRACTURED. THE PHYSICIAN WAS ABLE TO GRAB THE FRACTURED PART BUT IT STARTED TO UNWIND WHILE TAKING IT OUT FROM THE PATIENT. THE PHYSICIAN ENDED UP ACCESS VESSEL VIA CAROTID AND UTILIZED OTHER CATHETERS AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972277 ↗
• MalfunctionJun 19, 2020Fracture; Fracture

  THE SUBJECT CATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT CATHETER SHAFT WAS BROKEN/FRACTURED INSIDE THE PATIENT'S ANATOMY DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW CATHETER. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174957 ↗
• MalfunctionApr 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT MICROCATHETER HAD FRACTURED WHILE ADVANCING IN THE VESSEL. THE PHYSICIAN WAS ABLE TO COMPLETELY REMOVE THE SUBJECT DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925302 ↗
• MalfunctionMar 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A STROKE PROCEDURE, THE SUBJECT CATHETER BROKE FROM THE PROXIMAL HUB AREA WHILE BEING ADVANCED INTO THE COMMON CAROTID ARTERY INSIDE THE PATIENT'S ANATOMY. THE PHYSICIAN RETRIEVED THE BROKEN CATHETER AND USED A DIFFERENT CATHETER TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892314 ↗
• MalfunctionMar 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT CATHETER WAS BROKEN AT THE HUB DURING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851254 ↗
• MalfunctionFeb 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE RETRIEVING A CLOT FROM THE PATIENT'S ANATOMY, THE SUBJECT CATHETER SHAFT WAS NOTED BROKEN AT THE PROXIMAL END BY THE HUB. THE CLOT WAS RETRIEVED AFTER ONE PASS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9760147 ↗
• MalfunctionJan 15, 2020Fracture; Fracture

  BASED ON REVIEW OF THE INVESTIGATION OF THE RETURNED CATHETER (SUBJECT DEVICE), IT WAS REVEALED THAT THE CATHETER SHAFT WAS BROKEN/ FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593590 ↗
• MalfunctionDec 17, 2019Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND CATHETER WAS FRACTURED PROXIMALLY NEAR THE HUB. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9484706 ↗