AXS VECTA 46 INC-11814-146Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327519365), received between Sep 8, 2023 and Jun 24, 2026 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionJun 24, 2026Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE SHAFT OF THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611679 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER (SUBJECT DEVICE) WAS USED IN THE THROMBECTOMY PROCEDURE. HOWEVER, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE THROMBUS AS THE SUBJECT DEVICE WAS FELT TO BE LEAKING NEAR SHAFT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24425469 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT CATHETER FRACTURED DURING PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774768 ↗
• InjuryDec 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS TREATING A PATIENT FOR A LEFT P2 STROKE. ACCESS SETUP WAS THROUGH THE RADIAL ARTERY. AFTER APPROXIMATELY 1-1.5 MINUTES OF ASPIRATION, THE SUBJECT CATHETER WAS RETRACTED AND SOME RESISTANCE WAS FELT. THE SUBJECT CATHETER CAME BACK SLOWLY WITH THE RESISTANCE AND EVENTUALLY OUT OF THE NON-STRYKER CATHETER. A CONTRAST RUN WAS DONE TO CHECK IF P2 VESSEL WAS OPEN WHICH IT WAS AT THAT POINT. IT WAS THEN NOTICED THAT THE SUBJECT CATHETER WAS STRETCHED DISTALLY AND THE DISTAL FLUORO MARKER WAS STILL IN THE PATIENT'S VESSEL, BUT MORE DISTAL. THERE WAS NO ATTEMPT MADE TO RETRIEVE THE DISTAL MARKER AS IT WAS TOO FAR DISTAL IN THE ANATOMY. FOLLOWING THE CASE, THE NON-STRYKER WAS INSPECTED AND A KINK WAS NOTICED. NO ADDITIONAL INFORMATION AVAILABLE. UPDATE: ADDITIONAL INFORMATION RECEIVED ON 10-JAN-2024 STATED THAT INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18387220 ↗
• InjurySep 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBUS RETRIEVAL PROCEDURE, THE CATHETER (SUBJECT DEVICE) WAS GUIDED TO THE M2 AND MIGRATED WHEN THE MICROCATHETER WAS BEING ADVANCED TO THE PERIPHERAL. WHEN THE CATHETER (SUBJECT DEVICE) WAS PLACED IN CONTACT WITH THE THROMBUS, THE ASPIRATION PUMP WAS USED TO ASPIRATE THE THROMBUS AND SLOWLY PULL THE ASPIRATION CATHETER OUT, A REVERSE BLEEDING NEAR THE INTERNAL CAROTID PETROUS POTION WAS OBSERVED. CONTRAST WAS APPLIED AND A BLACK OBJECT WAS OBSERVED IN THE ANTERIOR CEREBRAL ARTERY. WHEN THE CATHETER (SUBJECT DEVICE) WAS REMOVED, THE MARKER WAS NOT PRESENT ON THE DEVICE. ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING MARKER WITH A STENT RETRIEVER AND FOLLOWING THAT A MICROCATHETER BUT BOTH ATTEMPTS WERE UNSUCCESSFUL. FOLLOWING THIS, A SECOND MICROCATHETER WAS REINSERTED TO ATTEMPT TO RETRIEVE THE REMAINING MARKER WHICH RESULTED IN THE MARKER TRAVELLING FURTHER DISTALLY AND REMAINED IN THE ANTERIOR CEREBRAL ARTERY. FOLLOWING THIS THE PROCEDURE WAS COMPLETED. THE PATIENTS CONDITION IS STABLE. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: Foreign Body In Patient

  MAUDE report 17715646 ↗