Direxion™ Fathom™-16 System M001195610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839606), received between Nov 27, 2018 and Nov 12, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE IN AN OVARIAN VEIN EMBOLIZATION PROCEDURE TO TREAT PELVIC CONGESTION SYNDROME. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT DURING COIL DEPLOYMENT. THE WHOLE MICROCATHETER WAS REMOVED AND A FRACTURE WAS FOUND HALFWAY DOWN THE MICROCATHETER. THE FRACTURED PORTION WAS IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041584 ↗
• MalfunctionNov 27, 2018Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THE HYDROPHILIC COVER OF THE DEVICE WAS DETACHED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. IT WAS FOUND OUT THAT THERE WAS FAILURE OF PROXIMAL RUPTURE OF THE CATHETER WITH DETACHMENT OF THE HYDROPHILIC COVER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8105859 ↗