Direxion™ Fathom™-16 System M001195650Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729839644), received between Mar 26, 2020 and Feb 9, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292568 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292549 ↗
• MalfunctionJan 13, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM WAS SELECTED FOR A COILING PROCEDURE TO TREAT AN ENDOLEAK. DURING THE PROCEDURE, HOWEVER, THE DIREXION FRACTURED. A NEW DIREXION? FATHOM?-16 SYSTEM WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053468 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT THE SHAFT BROKE. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR HEPATIC ARTERIAL CHEMOEMBOLIZATION OF THE RIGHT LIVER METASTASIS. ULTRASOUND GUIDED PUNCTURE OF THE LEFT DISTAL RADIAL ARTERY WAS PERFORMED FOLLOWED BY PLACEMENT OF A NON-BOSTON SCIENTIFIC (BSC) INTRODUCER. CATHETERIZATION OF THE SUPERIOR MESENTERIC ARTERY AND THEN THE RIGHT HEPATIC ARTERY WAS THEN PERFORMED USING A NON-BSC CATHETER AND A NON-BSC .035 GUIDEWIRE. DURING DISTAL MICROCATHETERIZATION OF THE RIGHT NETWORK WITH THE DIREXION FATHOM-16 SYSTEM, THE CATHETER BROKE INSIDE DURING A WITHDRAWAL ATTEMPT. THE ENTIRE SYSTEM HAD TO BE REMOVED. THE PROCEDURE WAS REPEATED WITH A NEW DIREXION MICROCATHETER WITH CHEMOEMBOLIZATION TREATMENT INJECTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082118 ↗
• MalfunctionOct 5, 2020Fracture; Material Deformation; Material Integrity Problem; Physical Resistance/Sticking; Fracture; Material Deformation; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GUIDEWIRE COATING PEELED. A DIREXION FATHOM-16 SYSTEM CATHETER INFUSION WAS SELECTED FOR USE IN A HEPATOCARCINOMA EMBOLIZATION. DURING THE PREPARATION, THE DIREXION MICROCATHETER WITH A PRELOADED GUIDEWIRE WAS PASSED INSIDE THE COIL. THE GUIDEWIRE WAS REMOVED FROM THE MICROCATHETER AND PLACED IT IN SALINE. THE COIL CONTAINING THE MICROCATHETER WAS FLUSHED. THE MICROCATHETER WAS REMOVED. RESISTANCE WAS NOTED UPON INSERTION DUE TO THE BENDING OF THE MICROGUIDE AND WAS UNABLE TO ENTER THE DIREXION. IT WAS OBSERVED THAT THE GUIDEWIRE WAS NOT SMOOTH AND ROUGHNESS IN THE GUIDEWIRE'S TIP, AS IF THE HYROPHILIC COATING WAS PEELED OFF AFTER PROPER HYDRATION. LASTLY, THE DIREXION WAS PLACED BACK ON THE COIL. THE COIL WAS ADVANCED. HOWEVER, THE SHAFT WAS BENT AND FRACTURED EXPOSING THE PEBAX LAYER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10626615 ↗
• MalfunctionMar 26, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE FRACTURED. A 155CM DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, RESISTANCE WAS NOTED UPON REMOVING THE FATHOM GUIDEWIRE FROM THE CATHETER AND UPON INSERTING IT AGAIN. HOWEVER, THE TIP OF THE GUIDEWIRE WAS NOTED TO BE FRACTURED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9882722 ↗