Direxion™ Fathom™-16 System M001195620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729839613), received between Oct 8, 2020 and Aug 25, 2023 — classified as 1 injury, 2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2023Break; Break

  IT WAS REPORTED THE DEVICE WAS BROKEN. A NGMC/FATHOM/021/STRAIGHT/1RO/155 DIREXION WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE MICROCATHETER WAS BROKEN. THE DEVICE WAS REMOVED AND THE DETACHED PORTIONS WERE SNARED OUTSIDE THE PATIENT. A PHOTO OF THE DEVICE IDENTIFIED A BREAK AT THE HUB AND THE DISTAL PORTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MICROCATHETER. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625161 ↗
• MalfunctionNov 3, 2021Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER BROKE. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE IN A COILING PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE IN THE MIDDLE OF COILING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749234 ↗
• MalfunctionOct 8, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A DIREXION FATHOM-16 SYSTEM WAS SELECTED FOR USE WITH A LIQUID EMBOLIC AGENT. DURING THE PROCEDURE, THE 30CM TIP OF THE FATHOM GUIDEWIRE DETACHED FROM THE GUIDEWIRE BODY. DURING REMOVAL, THE TIP OF THE GUIDEWIRE STUCK INSIDE THE MICROCATHETER. THERE WAS SOME LIQUID EMBOLIC AGENT REMAINING INSIDE THE MICROCATHETER WALL WHICH LIKELY ENTRAPPED THE TIP OF THE WIRE. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENTS STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649886 ↗