Direxion™ HI-FLO™ Fathom™-16 System M001195710Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729839682), received between Sep 21, 2018 and Nov 6, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OUTER SHAFT OF THE MICROCATHETER FRACTURED. A DIREXION? HI-FLO? FATHOM?-16 SYSTEM WAS SELECTED FOR USE IN A PROSTATE EMBOLIZATION PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. WHEN THE MICROCATHETER WAS REMOVED FROM THE PATIENT, IT WAS DISCOVERED THAT THE OUTER SHAFT HAD FRACTURED. THE INNER LUMEN OF THE DEVICE WAS STILL INTACT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486771 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER FRAYED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR USE IN A UTERINE FIBROID EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY CALCIFIED AND TORTUOUS. DURING USE, THE DISTAL TIP OF THE CATHETER FRAYED. A NEW DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR USE BUT THE SAME EVENT OCCURRED. IT WAS EXCHANGED FOR A NON-BSC CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968613 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER FRAYED. A DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR USE IN A UTERINE FIBROID EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY CALCIFIED AND TORTUOUS. DURING USE, THE DISTAL TIP OF THE CATHETER FRAYED. A NEW DIREXION HI-FLO MICROCATHETER WAS SELECTED FOR USE BUT THE SAME EVENT OCCURRED. IT WAS EXCHANGED FOR A NON-BSC CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968337 ↗
• MalfunctionJul 29, 2022Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT A DEVICE WAS FRACTURE OCCURRED. THE TARGET LESION WAS IN THE ESOPHAGEAL VARICOSE VEINS. A 130CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING ADVANCING TO THE LESION, THE FATHOM GUIDEWIRE WAS TRAPPED WITHIN THE CATHETER SYSTEM AND WAS REMOVED AS A UNIT. HOWEVER, THE DEVICE WAS NOTED TO BE FRACTURED ABOUT HALF OF THE CATHETER, BUT IT WAS CONFIRMED THAT THE DEVICE WAS COMPLETELY REMOVED WITHOUT LEAVING FRAGMENTS IN THE PATIENT'S BODY. AS PER PHYSICIAN'S OPINION, THE FRACTURE IS POSSIBLY DUE TO MANUFACTURING DEFECT. 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 15129214 ↗
• MalfunctionJan 25, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A DIREXION HI-FLO INFUSION CATHETER WAS SELECTED FOR USE IN A PROCEDURE. AFTER THE CATHETER HAD BEEN USED FOR EMBOLIZATION, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13349671 ↗
• MalfunctionMay 21, 2021Break; Difficult to Remove; Material Integrity Problem; Break; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS IN THE NOT VERY TORTUOUS UTERUS. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, THE CATHETER WAS USED TO EMBOLIZE A UTERINE FIBROID WITH EMBOLIC BEADS. SOME RESISTANCE WAS FELT IN THE FINAL APPROACH TO THE TARGET. PHYSICIAN THOUGHT THERE MIGHT BE VASOSPASM. THE EMBOLICS WERE DELIVERED AND UPON RETRACTION OF THE DEVICE, IT WAS NOTED THAT MORE RESISTANCE THAN THEY ARE TYPICALLY USED TO WAS FELT. USING VERY GENTLE PULLING FORCE, THE CATHETER WAS REMOVED AND THE SEPARATION OF THE YELLOW TIP FROM THE NITINOL TUBE WAS NOTICED. THE YELLOW TIP SHOWED SEPARATED FROM NITINOL HYPOTUBE; HOWEVER, IT DID NOT BECOME FULLY DETACHED AND WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vasoconstriction

  MAUDE report 11863407 ↗
• MalfunctionNov 21, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER FRAYED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PSI WAS PUSHED TO 1100, IT WAS NOTED THAT THE END OF THE CATHETER FRAYED. THE DEVICE WAS THEN SIMPLY REMOVED FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353687 ↗
• MalfunctionOct 11, 2019Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16SEP2019. IT WAS REPORTED THAT DEVICE WAS STUCK. A 027/STRAIGHT/1RO/130 DIREXION HI-FLO FATHOM 16 WAS SELECTED FOR USE. DURING THE PROCEDURE INSIDE THE PATIENT, IT WAS NOTED THAT THE CATHETER WAS STUCK IN THE LUMEN OF A NON-BSC DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE OUTER SHAFT WAS SEPARATED ABOUT 82 CM FROM THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179157 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ADRENAL VEIN. A DIREXION HI-FLO FATHOM-16 WAS SELECTED FOR USE. DURING THE PROCEDURE UPON REMOVAL OF THE DEVICE FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE CATHETER WAS FRACTURED APPROXIMATELY 25CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS JUST REMOVED OVER THE FATHOM WIRE AT WHICH TIME THE FRACTURE WAS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119524 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A 130 CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER SPLIT AT THE HUB AND ABOUT HALF WAY ALONG. 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 8616385 ↗
• MalfunctionSep 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-AUG-2018. IT WAS REPORTED THAT FRICTION OCCURRED BETWEEN THE DEVICE AND THE GUIDE CATHETER. A 130/27 DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WERE FRICTION BETWEEN THE PRELOADED DIREXION HI-FLO SYSTEM AND THE 0.038 NON- BSC GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURED SHAFT. THE DEVICE WAS RETURNED FOR ANALYSIS. THE RETURNED PRODUCT CONSISTED OF A DIREXION MICRO-CATHETER WITH A CORDIS .038 GUIDE CATHETER. THE SHAFT WAS MICROSCOPICALLY EXAMINED. THE DEVICE SHOWED DAMAGE IN THE FORM OF A FRACTURED SHAFT IN 1 LOCATION. THE LOCATION OF THE FRACTURE WAS 61.5CM FROM THE HUB. THE DEVICE WAS NOT COMPLETELY SEPARATED, THE INNER LINER WAS STILL INTACT. THE OUTER DIAMETER (OD) OF THE DIREXION CATHETER WAS MEASURED ON THE LED MICROMETER. THE MAXIMUM OD THAT WAS MEASURED WAS .0383. THE RETURNED .038 CORDIS GUIDE CATHETER (ID.041) WAS HYDRATED WITH FLUID AND THE DIREXION CATHETER WAS INSERTED INTO THE GUIDE CATHETER AND THE DEVICE TRANSCENDED THROUGH WITH NO HESITATIONS OR RESTRICT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897481 ↗