Direxion™ M001195340Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839453), received between Sep 27, 2018 and Dec 16, 2025 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Fracture; Nonstandard Device; Fracture; Nonstandard Device

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, DURING COIL ADVANCING, A FRACTURE OCCURRED AT THE CONNECTION POINT OF THE MICROCATHETER'S DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE ROTATION AT THE END FRACTURED. NO FRACTURED DEVICE WAS INSIDE THE PATIENT BECAUSE IT WAS COMPLETELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817174 ↗
• MalfunctionApr 5, 2024Defective Device; Difficult to Open or Remove Packaging Material; Material Deformation; Adverse Event Without Identified Device or Use Problem; Defective Device; Difficult to Open or Remove Packaging Material; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS COMPLETED 21MARCH2024. IT WAS REPORTED THAT THIS MICROCATHETER HAD KINKED. DURING IMAGING OF A RENAL EMBOLIZATION PROCEDURE USING A DIREXION MICROCATHETER, IT WAS FOUND THAT THE DEVICE WAS FAULTY DURING TRACKING THOUGH THE ANATOMY AND THE HUB HAD KINKED. IT WAS NOTED THAT THE CARRIER TUBE WAS HYDRATED PRIOR TO THE REMOVAL OF THE CATHETER; HOWEVER, THERE WAS A LITTLE RESISTANCE REMOVING THE CATHETER FROM THE CARRIER TUBE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE AND A DEVICE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049957 ↗
• MalfunctionMay 11, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER SPLIT. A 130 DIREXION CATHETER WAS SELECTED FOR USE IN A HEPATIC ARTERY CHEMOEMBOLIZATION PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE MID-SECTION OF THE CATHETER RIPPED AND SPLIT WHILE DELIVERING THE CHEMO-AGENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE THROUGHOUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042846 ↗
• MalfunctionSep 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS MESENTERICA SUPERIOR. A DIREXION MICROCATHETER WAS USED FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE NITINOL SHAFT OF THE MICROCATHETER BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD. DEVICE EVAL BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A DIREXION MICROCATHETER. THE SHAFT WAS MICROSCOPICALLY EXAMINED. THE DEVICE SHOWED DAMAGE IN THE FORM OF A SEPARATED SHAFT IN 2 LOCATIONS. THE 1ST LOCATION WAS 43CM FROM THE HUB AND THE 2ND LOCATION WAS 44.2CM FROM THE HUB. THE SHAFT SHOWED SOME SLIGHT BENDS FROM THE TIP PROXIMALLY 12CM. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914980 ↗