Direxion HI-FLO Fathom-16 SystemRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of Direxion HI-FLO Fathom-16 System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and May 12, 2026 — classified as 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Break” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Direxion HI-FLO Fathom-16 System problems
Device problems
- Break18
- Fracture9
- Entrapment of Device8
- Detachment of Device or Device Component7
- Adverse Event Without Identified Device or Use Problem4
- Difficult to Remove3
- Material Deformation3
- Stretched3
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient13
- Vasoconstriction2
- Erosion1
- Failure of Implant1
Direxion HI-FLO Fathom-16 System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Direxion™ HI-FLO™ Fathom™-16 System M001195740Catheter, continuous flush20 reports
- Direxion™ HI-FLO™ Fathom™-16 System M001195710Catheter, continuous flush11 reports
- Direxion™ HI-FLO™ Fathom™-16 System M001195750Catheter, continuous flush9 reports
- Direxion™ HI-FLO™ Fathom™-16 System M001195960Catheter, continuous flush1 report
Recent Direxion HI-FLO Fathom-16 System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2026Entrapment of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DIREXION PUSHED THROUGH BASE CATHETER, HOWEVER, BECAME STUCK WHEN TRYING TO RETRACT BACK INTO THE BASE CATHETER. THE DIREXION SEEMS TO BE GETTING CAUGHT WHERE THE NITINOL HYPOTUBE AND YELLOW DISTAL TIP ARE GLUED TOGETHER. DIREXION WILL PULL BACK INTO BASE CATHETER SMOOTHLY UNTIL THAT POINT MAKES CONTACT WITH THE DISTAL TIP OF THE BASE CATHETER. SEEMS AS IF THE JUNCTION BETWEEN HYPOTUBE AND DISTAL TIP IS TOO BIG TO PULL BACK INTO THE BASE CATHETER THEN GETS STUCK. ONCE STUCK, THE DIREXION CANNOT BE ADVANCED FORWARD EITHER. THE MICROCATHETER AND BASE CATHETER WERE REMOVED AS ONE BECAUSE THE MICROCATHETER WAS STUCK AND COULD NOT BE RETRACTED SEPARATELY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153679 ↗MalfunctionMar 24, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A DIREXION HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP END WAS BROKEN AND LEAKING LIQUID. 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 24680509 ↗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 ↗InjuryApr 23, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VESSEL SPASM REQUIRING INTERVENTION. PATIENT WAS UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS HEPATIC ARTERY. A DIREXION HI-FLO FATHOM, 16 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON DELIVERING THE DOSE, IT WAS NOTED THAT THE NITINOL HYPOTUBE BROKE IN HALF REVEALING THE YELLOW SHEATH. UPON REMOVING THE MICROCATHETER, VESSEL SPASM OCCURRED. AN INTERVENTION WAS PERFORMED WITH NO LUCK TO OPEN BACK UP THE VESSEL. THE PROCEDURE WAS CANCELLED.
Patient problems: Vasoconstriction
MAUDE report 21893692 ↗MalfunctionFeb 13, 2025Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A DIREXION HI-FLO WAS SELECTED FOR USE IN A VESSEL OF THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING INSERTION, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21375473 ↗MalfunctionJan 2, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT THE HUB DETACHED. THE PATIENT PRESENTED WITH BLEEDING FROM THE STOMACH AND HAD COME FROM THE INTENSIVE CARE UNIT (ICU). PROFUSE BLEEDING HAD BEEN OBSERVED WITHIN THE PRIOR 12 HOURS. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE TO PLACE COILS IN THE LEFT GASTRIC ARTERY. AFTER TWO UNSUCCESSFUL ATTEMPTS TO INSERT COILS THROUGH THE DIREXION HI-FLO CATHETER HUB, THE HUB DETACHED. NO MASSIVE BLEEDING OCCURRED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN GUIDEWIRE IN THE DISTAL TIP OF THE CATHETER SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21058546 ↗MalfunctionOct 7, 2024Fracture; Fracture
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR LIVER CANCER TREATMENT. HOWEVER, UPON REMOVAL, IT WAS NOTED THAT THE OUTER LAYER OF THE CATHETER, WHICH WAS DISTAL TO THE STRAIN RELIEF, HAD SEPARATED. THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392241 ↗MalfunctionAug 14, 2024Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE OUTER SHAFT BROKE. A DIREXION HI-FLO CATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. THE OUTER SHAFT OF THE CATHETER BROKE WHILE INSIDE THE PATIENT DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND EXCHANGED FOR A NEW DEVICE, SAME MODEL. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983624 ↗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 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE MICROCATHETER FRACTURED. AN 0.027IN BERN 130CM DIREXION HI-FLO FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. THE PATIENT WAS BEING TREATED FOR LIVER CANCER. THE TARGET VESSEL WAS MILDLY TORTUOUS. DURING USE OF THE DIREXION MICROCATHETER TOGETHER WITH THE FATHOM GUIDEWIRE, THE DIREXION BROKE COMPLETELY AT APPROXIMATELY 20CM FROM THE HUB. ALL PARTS WERE ABLE TO BE PULLED FROM THE PATIENT, AND THE DIREXION WAS REPLACED WITH A RENEGADE MICROCATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18551938 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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