Renegade™ HI-FLO™ FATHOM™ System M001184520Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729790839), received between Aug 3, 2018 and Aug 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2018Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT A WIRE FRACTURE OCCURRED. A RENEGADE¿ HI-FLO¿ FATHOM¿ SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FATHOM¿WIRE WAS USED IN INTERVALS FOR APPROXIMATELY 1 HOUR. UPON WITHDRAWAL, IT WAS NOTICED THAT THE TIP OF THE WIRE WAS DETACHED. THE TIP WAS LEFT A FEW CM OUTSIDE THE MICROCATHETER. WHEN PULLING BACK THE WIRE OUTSIDE THE PATIENT, THE TIP GOT STUCK INTO THE MICROCATHETER AND THEN THE WHOLE MICROCATHETER WAS PULLED OUT OF THE PATIENT. THE MICROCATHETER WAS THEN FLUSHED AND THE 10 CM OF THE BROKEN OFF TIP FLUSHED OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748186 ↗