Direxion™ HI-FLO™ Fathom™-16 System M001195750Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729839729), received between Mar 19, 2019 and Apr 3, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Entrapment of Device; Detachment of Device or Device Component; Positioning Problem; Entrapment of Device; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT TIP DETACHMENT, REMOVAL DIFFICULTY, AND EXTRUSION OCCURRED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A UTERINE FIBROID EMBOLIZATION PROCEDURE. THE TARGET LESION WAS REPORTED TO BE 20% STENOSED WITH MILD TORTUOSITY AND CALCIFICATION. WHILE ADVANCING THE SYSTEM WITHIN THE RIGHT UTERINE ARTERY, RESISTANCE WAS ENCOUNTERED. IMAGING APPEARED TO SHOW THE FATHOM WIRE WAS DOUBLE BACKED UP ON ITSELF AND WRAPPED AROUND THE TIP OF MICROCATHETER. DURING WIRE REMOVAL FOR INJECTION OF EMBOLIZATION PARTICLES, IT WAS NOTED THAT THE WIRE WAS DIFFICULT TO REMOVE, AND EXTRA TENSION WAS APPLIED TO PULL THE WIRE FROM THE MICROCATHETER. INJECTION THROUGH THE MICROCATHETER WAS COMPLETED AND EMBOLIZATION WAS DONE. DURING MICROCATHETER REMOVAL, HIGHER THAN NORMAL RESISTANCE WAS ENCOUNTERED. WHEN THE MICROCATHETER WAS REMOVED, IT WAS NOTED THAT 3-5 CM FROM DISTAL TIP OF THE MICROCATHETER HAD DETACHED. SUBSEQUENT ANGIOGRAPHY REVEALED THAT THE MICROCATHETER TIP WAS NOT IN THE UTERINE ARTERY. NORMAL RADIAL PRESSURE WAS PERFORMED, AND THE PATIENT WAS DISCHARGED WITHOUT INCIDENT. HOWEVER, SEVERAL DAYS LATER, THE PATIENT CALLED AND REPORTED THAT SHE HAD PULLED OUT WHAT SHE BE

  Patient problems: Erosion

  MAUDE report 19034430 ↗
• MalfunctionAug 10, 2023Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUL2023. IT WAS REPORTED THAT THE CATHETER BECAME LODGED IN BOTH OF THE NON BOSTON SCIENTIFIC GUIDE CATHS USED. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT DIREXION 2.8FR CATHETER BECAME LODGED IN BOTH OF THE NON-BOSTON SCIENTIFIC GUIDE CATHS USED. THE AMOUNT OF SALINE FLUSHED AROUND GUIDECATHS WAS INCREASED TO ENSURE HYDROPHILIC COATING WAS ACTIVATED IN THE INNER LUMEN OF THE GUIDECATHS. THE DEVICE WAS REMOVED AS ONE UNIT ALONG WITH THE GUIDECATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502028 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT WAS UNDERGOING A UTERINE FIBROID EMBOLIZATION (UFE) PROCEDURE TO TREAT POLYPS. A NGMC/FATHOM/027/BERN/1RO/155 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DIREXION HI-FLO WAS DETACHED IN THE VALVE OF THE SHEATH UPON INSERTION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION MICROCATHETER. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811726 ↗
• MalfunctionApr 13, 2023Break; Failure to Advance

  MID 50¿S FEMALE WITH HISTORY OF FIBROIDS AND MENORRHAGIA. PROCEDURE: IR EMBOLIZATION- BILATERAL UTERINE ARTERY EMBOLIZATION AND IMAGE GUIDED SUPERIOR HYPOGASTRIC NERVE BLOCK. DEVICE 1- WIRE WOULD NOT FEED INTO CATHER. DEVICE 2- MICROCATHETER BROKEN @ HUB. #3 OBTAINED AND USED WITHOUT ISSUES. NO KNOWN HARM TO PATIENT, MINOR DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION¿ HI-FLO¿ (PER SITE REPORTER) WILL OBTAIN. MANUFACTURER RESPONSE FOR CATHETER, CONTINUOUS FLUSH, DIREXION¿ HI-FLO¿ FATHOM¿-16 SYSTEM (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Failure of Implant

  MAUDE report 16731515 ↗
• MalfunctionJul 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS VESSEL IN THE UTERUS. A 155CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS MANEUVERED OVER THE FATHOM WIRE INTO THE UTERINE ARTERY, HOWEVER THE PHYSICIAN NOTICED THE CATHETER WAS NOT RESPONDING TO THE TORQUE. THE DEVICE WAS THEN PULLED OUT, INTACT, BUT A FRACTURE WAS OBSERVED APPROXIMATELY AT THE MIDPOINT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122752 ↗
• MalfunctionOct 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE UTERINE FIBROIDS. A 155 DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WASN'T RESPONDING WHEN STARTED TO TORQUE THE MICROCATHETER. THE DEVICE WAS SIMPLY PULLED FROM THE DIAGNOSTIC CATHETER INTACT, HOWEVER, A FRACTURE WAS OBSERVED MIDPOINT OF THE CATHETER UPON REMOVAL. THE DEVICE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674671 ↗
• MalfunctionSep 4, 2020Difficult to Remove; Stretched; Material Deformation; Difficult to Remove; Stretched; Material Deformation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE. VASCULAR ACCESS WAS OBTAINED VIA RADIAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS OVARIAN VEIN. A 155 DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, AN ANGIO DYNAMICS SOFT VU 5FR DIAGNOSTIC CATHETER WAS INSERTED INTO THE LEFT GONADAL VEIN AFTER OBTAINING RADIAL ACCESS VIA A 5FR SHEATH. SUBSEQUENTLY, THE FATHOM GUIDEWIRE WAS INSERTED THROUGH THE ANGIO DYNAMICS CATHETER DOWN INTO THE LEFT GONADAL VEIN. THE DIREXION CATHETER WAS ADVANCED OVER THE FATHOM GUIDEWIRE AND WAS ABLE TO CANNULATE THE VEIN. PUSHABLE COILS WERE DELIVERED AFTER CORRECT POSITIONING WAS CONFIRMED AND EMBOLIZATION WAS COMPLETED. HOWEVER, EXCESSIVE RESISTANCE WAS NOTED UPON PULLBACK OF THE DIREXION CATHETER. THE DIREXION AND ANGIO DYNAMICS CATHETER WERE THEN REMOVED TOGETHER AND THE TIP OF THE DIREXION WAS THEN NOTED TO BE STRETCHED AND MALFORMED. THE PROCEDURE WAS COMPETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494090 ↗
• MalfunctionJun 10, 2020Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A Y90 MAPPING PROCEDURE. A RADIAL ACCESS APPROACH WAS USED. DURING PROCEDURE, UPON ADVANCEMENT OF THE DIREXION MICROCATHETER THRU THE NON-BSC DIAGNOSTIC CATHETER, THE PHYSICIAN NOTED THAT RESISTANCE WAS MET WITHIN THE BASE CATHETER DUE TO THE TORTUOUS ANATOMY. THE DIREXION FRACTURED AT THE HUB AND WAS DIFFICULT TO REMOVE. THE ENTIRE SYSTEM WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138668 ↗
• MalfunctionMar 19, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL APPROACH. THE TARGET LESION WAS LOCATED IN RIGHT UTERINE ARTERY. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS FOUND OUT THAT THE CATHETER WAS KINKED AND FRACTURED IN Y-ADAPTER; ONE FRACTURE RIGHT AT THE HUB AND THE OTHER ABOUT 15-20CM FROM THE HUB. CONSEQUENTLY, IT WAS DIFFICULT TO INJECT MICROSPHERES SO THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY. ANOTHER OF THE SAME CATHETER WAS USED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8433662 ↗