Direxion Fathom-16 SystemRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of Direxion Fathom-16 System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Sep 25, 2018 and Apr 1, 2026 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Break” (15 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 Fathom-16 System problems
Device problems
- Break15
- Fracture10
- Detachment of Device or Device Component7
- Adverse Event Without Identified Device or Use Problem5
- Material Integrity Problem5
- Entrapment of Device4
- Difficult to Remove3
- Difficult to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient2
- Insufficient Information1
- No Patient Involvement1
Direxion Fathom-16 System models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Direxion™ Fathom™-16 System M001195640Catheter, continuous flush18 reports
- Direxion™ Fathom™-16 System M001195650Catheter, continuous flush6 reports
- Direxion™ Fathom™-16 System M001195610Catheter, continuous flush4 reports
- Direxion™ Fathom™-16 System M001195670Catheter, continuous flush4 reports
- Direxion™ Fathom™-16 System M001195620Catheter, continuous flush3 reports
- Direxion™ Fathom™-16 System M001195660Catheter, continuous flush1 report
Recent Direxion 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.
MalfunctionApr 1, 2026Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE FRACTURED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BECAME FRACTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DIREXION FATHOM MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION WAS POSITIVE POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756367 ↗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 ↗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 ↗MalfunctionNov 12, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A DIREXION? FATHOM?-16 SYSTEM CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE CATHETER. UPON REMOVAL, IT WAS OBSERVED THAT THE CATHETER HAD FRACTURED. THE PROCEDURE WAS COMPLETED USING 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 23533621 ↗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 ↗MalfunctionOct 11, 2024Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A DIREXION FATHOM-16 SYSTEM WAS USE FOR GENICULAR ARTERY EMBOLIZATION(GAE). DURING THE PROCEDURE, THE DIREXION CATHETER WAS NOT FUNCTIONING AS EXPECTED. UPON REMOVAL, THE CATHETER WAS FOUND TO BE BROKEN ABOUT 5 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20429057 ↗MalfunctionOct 1, 2024Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT INTERNAL CATHETER BREAK OCCURRED. THE NON- STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LEFT KNEE VESSEL. A 021/BERN/2RO/130 DIREXION CATHETER INFUSION WAS SELECTED FOR USE. DURING THE EMBOLIZATION PROCEDURE, THE CATHETER FELT OBSTRUCTED AND WAS NO LONGER DELIVERING ANY BEADS. UPON REMOVAL OF THE MICROCATHETER, IT WAS OBSERVED THAT THE CATHETER WAS BROKEN ALONG THE SHAFT AND TWISTED, 6-7 INCHES DISTAL TO THE HUB. 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 20349015 ↗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 ↗MalfunctionAug 29, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE CORE WIRE FRACTURED. A DIREXION INFUSION CATHETER KIT SUPPLIED WITH A FATHOM GUIDEWIRE WAS SELECTED FOR USE. DURING USE, IT WAS NOTED THAT THE LAST FEW FATHOM GUIDEWIRES SUPPLIED IN THE DIREXION CATHETER KIT LOST THEIR SHAPE QUICKLY, EVEN DURING THE FIRST RECONFIGURATION. IN ONE FATHOM GUIDEWIRE, IT RESULTED A FRACTURE OF THE CORE WIRE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE, SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20101444 ↗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 ↗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 ↗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 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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