Renegade™ HI-FLO™ FATHOM™ System M001184560Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729790877), received between Sep 10, 2018 and Apr 29, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED INSIDE THE PATIENT. A 180CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE IN A HEPATIC HEMORRHAGIC EMBOLIZATION OF THE RIGHT HEPATIC ARTERY. AFTER REPOSITIONING THE MICROCATHETER AND GUIDEWIRE, NEAR THE END OF THE PROCEDURE, FLUOROSCOPY REVEALED A RADIOPAQUE BLACK OBJECT. AFTER A VISUAL INSPECTION, THE GUIDEWIRE WAS INCOMPLETE, AND THE ARTIFACT PREVIOUSLY OBSERVED VIA FLUOROSCOPY CORRESPONDED TO A 10CM SEGMENT OF THE GUIDEWIRE WHICH HAD EMBOLIZED TO A RIGHT HEPATIC BRANCH. IT WAS NOTED THAT THE EMBOLIZED DEVICE FRAGMENT WAS SERVING AS AN EMBOLIZATION MATERIAL AND ITS RETRIEVAL WAS NOT NEEDED AS IT WAS HELPING TO ENSURE NO RECANALIZATION OF BLEEDING WOULD BE NEEDED ON THE EMBOLIZED BRANCHES. RADIOGRAPHIC IMAGES CONFIRMED THAT THE OBJECT COULD NOT BE REMOVED; THEREFORE, IT REMAINED IN THE PATIENT. THE PHYSICIAN INDICATED THAT THE OBJECT DID NOT PRESENT HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND CONSEQUENTLY TO AN ONCOLOGY WARD FOR CONTINUED CARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19205619 ↗
• MalfunctionOct 18, 2023Difficult to Remove; Stretched; Detachment of Device or Device Component; Material Integrity Problem; Difficult to Remove; Stretched; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT THE MICROCATHETER PULLED APART AND THE OUTER COATING SPLIT. A FATHOM 16 180CM RENHF 150CM 10 PRELOAD RENEGADE HI FLO MICROCATHETER SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS GETTING STUCK WITHIN THE DIAGNOSTIC CATHETER. A TIGHT PUSH WAS NEEDED, AND THE DEVICE WAS ABLE TO BE ADVANCED FOR TREATMENT. WHEN THE DEVICE WAS PULLED OUT AND CHECKED, THE MICROCATHETER PULLED APART AND STRETCHED. THE COATING LAYER SPLIT AND SEPARATED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS NOT HARMED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957064 ↗
• MalfunctionFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS VESSEL IN THE LIVER. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING ADVANCEMENT OF THE DEVICE TO THE LESION, RESISTANCE OCCURRED. IT WAS NOTED THAT THE TIP OF THE FATHOM GUIDEWIRE BROKE FOLLOWING REMOVAL OF THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO RECAPTURE ALL THE PIECES OF THE DEVICE FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16294790 ↗
• MalfunctionJul 22, 2020Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE GUIDEWIRE COVERING BECAME SEPARATED FROM THE WIRE. A 180CMX150CMX10 RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING REMOVAL FROM THE PROTECTIVE PACKAGING HOLDER, IT WAS NOTED THAT THE GUIDEWIRE COVERING BECAME SEPARATED FROM THE WIRE. THE MICROCATHETER AND WIRE WERE ALSO STUCK IN THE HOLDER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311224 ↗
• MalfunctionFeb 28, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. THE CATHETER BROKE WHEN PASSING THE EMBOLIZATION COIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770278 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE FOR AN EMBOLIZATION FOR AN EVAR LEAK. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS NAVIGATING THE DEVICE IN THE ARTERY, IT WAS NOTED THAT THE CATHETER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353953 ↗
• MalfunctionOct 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CATHETER RUPTURE OCCURRED. A RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE AND DURING MANUAL INJECTION OF CONTRAST MEDIUM VIA A NON BSC SYRINGE THE CATHETER RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934929 ↗
• MalfunctionSep 10, 2018Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS IN PIECES. A 180CM X150CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE CATHETER WAS IN PIECES; DEVICE NEVER WENT INSIDE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7859931 ↗