Direxion™ Fathom™-16 System M001195670Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729839668), received between Apr 7, 2023 and Apr 1, 2026 — classified as 4 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. 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.

• 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 ↗
• 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 ↗
• MalfunctionApr 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE. DURING THE EMBOLIZATION PROCESS WITH A COIL, THE CATHETER WAS NOTED TO BE FRACTURED AFTER THE PROCEDURE ON SUPRA DISTAL. THE DEVICE WAS SIMPLY REMOVED WITHOUT ANY INTERVENTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702004 ↗