Direxion™ Fathom™-16 System M001195640Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729839637), received between Sep 25, 2018 and Dec 5, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE CATHETER WAS FLUSHED, IT WAS NOTED TO BE BROKEN UPON WITHDRAWAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728347 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A DIREXION FATHOM -16 SYSTEM WAS USED FOR TREATMENT. DURING THE PROCEDURE, DEHISCENCE OF THE MICROCATHETER WAS NOTED. AT THIS POINT, ONLY A SMALL AMOUNT OF THE DRUG WAS LEFT IN THE MICROCATHETER. SUBSEQUENTLY, THE MICROCATHETER SYSTEM WAS WITHDRAWN, AND THE PROCEDURE WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437245 ↗
• MalfunctionMar 17, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE OF ABDOMINAL VESSELS. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE MICROCATHETER, THE CATHETER LOST ITS TIP. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625024 ↗
• MalfunctionSep 20, 2024Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. THE PATIENT HAD A CURVED VESSEL ANATOMY. THE DEVICE WAS HARD TO INTRODUCE MORE DISTALLY. UPON REMOVAL, IT WAS NOTED THAT THE OUTER LAYER OF THE DEVICE SPLIT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ONLY THE OUTER SHAFT FRACTURED, AND THE INNER LUMEN WAS STILL INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266299 ↗
• MalfunctionMay 6, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE MICROCATHETER BECAME STUCK AND COULD NOT BE WITHDRAWN, AND THE COATING OF THE CATHETER PEELED OFF. A DIREXION FATHOM-16 SYSTEM FOR USE. DURING INSERTION, IT WAS NOTED THAT THE MICROCATHETER WAS A BIT STUCK. HOWEVER, THE PHYSICIAN CONTINUED TO FINISH THE PROCEDURE. UPON WITHDRAWAL, IT WAS NOTED THAT IT BECAME COMPLETELY STUCK AND COULD NOT BE WITHDRAWN. THE WIRE WAS REPLACED, AND THE CATHETER WAS WITHDRAWN TOGETHER WITH THE WIRE. UPON CHECKING, THE COATING ON THE MIDDLE OF THE CATHETER PEELED OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249525 ↗
• MalfunctionJan 30, 2024Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE OUTER LAYER OF THE MICROCATHETER PEELED OFF. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE IN THE JOINT EMBOLIZATION PROCEDURE. THE DIREXION FATHOM-16 SYSTEM WAS INTRODUCED VIA THE GUIDE SHEATH. DURING ADVANCEMENT, IT WAS NOTED THAT THE DIREXION WAS UNABLE TO BE CONTROLLED IN THE SAME MANNER IN WHICH IT USUALLY WAS. THE PHYSICIAN ELECTED TO REPLACE THE DIREXION, BUT THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE GUIDE SHEATH. ONCE THE DIREXION WAS REMOVED, IT WAS OBSERVED THAT THE OUTER LAYER OF THE DEVICE COATING HAD COME OFF. THE DIREXION WAS REPLACED WITH ANOTHER DIREXION, AND THE PROCEDURE WAS COMPLETED USING THE SECOND DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS, AND THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610002 ↗
• MalfunctionJun 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURE OCCURRED. A DIREXION MICROCATHETER WAS SELECTED FOR USE. THE LESION WAS ACCESSED THROUGH THE FEMORAL ARTERY IN THE RIGHT GROIN AND THE DEVICE WAS ADVANCED TO THE TARGET LESION. DURING REMOVAL OF THE MICROCATHETER, AN ABNORMALITY WAS OBSERVED NEAR THE TIP OF THE DEVICE. THERE WAS A SPLIT AT THE TIP AND IT LOOKED DAMAGED AND WORN OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877579 ↗
• MalfunctionJun 8, 2022Fracture; Failure to Advance; Fracture; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17MAY2022. IT WAS REPORTED THAT THE DEVICE WAS FRACTURED AT THE HUB. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT PROSTATE ARTERY. A NGMC/FATHOM/021/BERN/1RO/130 DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED AT THE PROXIMAL HUB. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE DEVICE WAS FRACTURED 25.3CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632717 ↗
• MalfunctionApr 1, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO NGMC/FATHOM/021/BERN/1RO/130 DIREXION FATHOM-16 SYSTEM WERE SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE GOT STUCK IN THE CATHETER WAS NOTED. A NEW J-SHAPE DIREXION CATHETER WAS OPENED, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN ABORTED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972340 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ARTERY IN THE KNEE AREA. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, BOTH NON BOSTON SCIENTIFIC GUIDEWIRE AND THE CATHETER BECAME VERY JUMBLED UP. THE DEVICE WAS HYDRATED PRIOR TO REMOVAL OF THE DEVICE. WHEN THE DEVICE WAS REMOVED COMPLETELY, IT WAS NOTED THAT THE CATHETER WAS BROKEN 3 INCHES FROM THE TIP OF THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384683 ↗
• MalfunctionMay 27, 2021Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, THE MICROCATHETER WAS IN PATIENT AND ATTACHED TO THE VICTORIA SYRINGE FROM THE VECTORIO SYSTEM. THE SYRINGE HAD LIPIODOL, DOXORUBIUN AND VISIPAQUE IN IT TO ADMINISTER TO PATIENT. THE LIPIODOL/DOXORUBIUN COMBINATION WAS GIVEN AT APPROXIMATELY 1500 AND WAS BEING SLOWLY PUSHED FOR APPROXIMATELY 10 MINUTES. AFTER IT WAS ADMINISTERED, IT WAS NOTED THAT THE OUTER RIM AT THE HUB OF THE MICROCATHETER COULD NOT BE REMOVED AS IT HAD MELTED. THE PHYSICIAN WAS UNABLE TO GIVE PARTICLES DUE TO MALFUNCTION MICROCATHETER AND HAD TO BE REMOVED. THE PROCEDURE WAS CANCELLED AS A RESULT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11894050 ↗
• MalfunctionMay 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE RIPPED OFF. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE TO TREAT BLOCKAGE IN THE BILE DUCTS. DURING THE PROCEDURE, THE TIP OF THE FATHOM GUIDEWIRE RIPPED OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853241 ↗
• MalfunctionFeb 4, 2021Fracture; Fracture

  IT WAS REPORTED THE OUTER SHAFT FRACTURED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE MODERATELY TORTUOUS VESSEL TO TREAT BLEEDING. DURING THE PROCEDURE WHILE ATTEMPTING TO TORQUE THE DEVICE, THE OUTER NICKEL SHAFT FRACTURED AND CAME LOOSE FROM THE INNER SHAFT INSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DIREXION FATHOM-16 SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280684 ↗
• MalfunctionDec 14, 2020Obstruction of Flow; Obstruction of Flow

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED 08DEC2020: IT WAS REPORTED THERE WAS AN OCCLUSION IN THE CATHETER. A DIREXION INFUSION CATHETER WAS SELECTED FOR USE. 100 MICRONS OF ONCOZENE MICROSPHERES WERE HAND INJECTED THROUGH THE CATHETER. HOWEVER, THE MICROSPHERES CLUMPED TOGETHER AND OCCLUDED THE CATHETER 20CM FROM THE CATHETER TIP. A WIRE WAS USED TO HELP THE OCCLUSION BUT THEY COULD NOT INJECT MORE MICROSPHERES. HOWEVER, THE PRODUCT INVESTIGATION REVEALED A OUTER SHAFT FRACTURE 3.2CM FROM THE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11005942 ↗
• MalfunctionSep 2, 2020Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS TYPE II ENDO LEAK. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER DELIVERING THREE COILS AND UPON TWISTING THE HUB OF THE MICROCATHETER, IT WAS NOTED THAT THE HUB BROKE OUTSIDE THE PATIENT'S BODY AND WAS UNABLE TO DEPLOY ANY MORE. THE MICROCATHETER WAS COMPLETELY REMOVED AND THE PHYSICIAN LOST ACCESS AND WAS UNABLE TO COMPLETE THE PROCEDURE. THE PATIENT MAY STILL HAVE ENDO LEAK AND MAY HAVE TO BE REBOOKED, AND WILL REQUIRE CT IMAGING TO ASSESS THE ENDO LEAK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482784 ↗
• MalfunctionAug 10, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ACCESS APPROACH. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS ADVANCING/MANIPULATING THE DIREXION MICROCATHETER THROUGH A NON-BSC DIAGNOSTIC CATHETER, HE MET RESISTANCE WITHIN THE BASE CATHETER POSSIBLY DUE TO THE TORTUOUS ANATOMY. AT THAT POINT, IT WAS NOTED THAT THE DIREXION MICROCATHETER FRACTURED AND WAS REMOVED. THE ENTIRE SYSTEM WAS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384634 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT THE SHEATH BROKE. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT OUTER SHEATH PART BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE CASE WAS DELAYED BUT NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090916 ↗
• MalfunctionSep 25, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER SHAFT FRACTURED. A DIREXION INFUSION CATHETER WAS SELECTED FOR USE FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE NITINOL HYPOTUBE SHAFT ON THE CATHETER FRACTURED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7906927 ↗