Renegade™ HI-FLO™ FATHOM™ System M001184540Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729790853), received between Sep 28, 2018 and Sep 18, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Entrapment of Device

  It was reported that device entrapment occurred.The target lesion was located in the left anterior descending vessel. A Renegade HI-FLO FATHOM System was selected for use during a Transcatheter Arterial Chemoembolization (TACE) procedure. During the procedure, the device was advanced; however, the guidewire and catheter became entrapped at a certain position and could neither be advanced nor withdrawn. Multiple attempts were made to resolve the issue, but the problem persisted. As a result, the guidewire and catheter were removed together with the angiography catheter. The procedure was completed with another of the same device. There were no patient complications as a result of this event. The patient remained stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818444 ↗
• MalfunctionAug 18, 2026Degraded; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306547 ↗
• MalfunctionDec 10, 2025Degraded; Degraded

  IT WAS REPORTED THAT THE HYDROPHILIC COATING WAS MISSING. THE TARGET LESION WAS LOCATED IN THE LIVER. A RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING PREPARATION, THE HYDROPHILIC COATING WAS MISSING AND INCOMPLETE. THE PROCEDURE WAS COMPLETED 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 23769369 ↗
• MalfunctionNov 20, 2025Device Misassembled During Manufacturing /Shipping; Difficult to Advance; Device Misassembled During Manufacturing /Shipping; Difficult to Advance

  IT WAS REPORTED THAT THE MICROCATHETER IN THIS SYSTEM WAS THE INCORRECT CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 180CM RENHF 135CM RENEGADE HI-FLO FATHOM SYSTEM 10 PRELOAD WAS SELECTED FOR UTERINE FIBROID EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE MICROCATHETER IN THIS SYSTEM WAS THE INCORRECT CATHETER, AND THE DEVICE COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENHF PRELOAD SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607539 ↗
• MalfunctionOct 17, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED, THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LIVER. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE IN THE LIVER DIGITAL SUBTRACTION ANGIOGRAPHY INTERVENTION. DURING INTRODUCTION, THERE WAS A PROBLEM WITH THE GUIDE WIRE, AND IT COULD NOT BE DRAWN OUT. THE PROCEDURE WAS COMPLETED 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 23324385 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN UPON UNPACKING. A 180 CM X 135 CM RENEGADE? HI-FLO? FATHOM? SYSTEM MICROCATHETER WAS SELECTED FOR TRANSCATHETER ARTERIAL EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE BODY OF THE MICROCATHETER WAS BROKEN WHEN OPENED FROM THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505790 ↗
• MalfunctionJun 9, 2025Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE IN A SPLENIC ARTERY EMBOLIZATION. DURING UNPACKING, IT WAS NOTED THAT THERE WERE OBVIOUS GLUE OR PLASTIC PROTRUDED ON THE COATING OF THE GUIDE WIRE, WHICH COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED 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 22169898 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE BREAK OCCURRED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON OPENING THE PACKAGING, IT WAS NOTED THAT THE GUIDEWIRE WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044594 ↗
• MalfunctionNov 6, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON OPENING THE PACKAGING, IT WAS NOTED THAT THE ASEPTIC PACKAGE WAS NOT COMPLETELY SEALED, AND THE STERILITY OF THE DEVICE WAS CONSIDERED COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620323 ↗
• MalfunctionAug 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER COATING PEELED OFF. THE PATIENT UNDERWENT A PULMONARY EMBOLISM DUE TO PULMONARY HEMORRHAGE. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, IT WAS FOUND THAT THE HYDROPHILIC COATING OF THE MICROCATHETER KIT PEELED OFF. THE DEVICE WAS NOT USED ON THE PATIENT AND WAS REPLACED FOR ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005365 ↗
• MalfunctionMay 14, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). AFTER UNPACKING, IT WAS NOTED THAT THE ASEPTIC PACKAGE WAS NOT COMPLETE. CONSEQUENTLY, THE PACKAGING SEAL AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312154 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 180CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, THE CATHETER WAS FOUND TO BE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651377 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE AT THE MIDWAY POINT. A RENEGADE FATHOM-16 WAS SELECTED FOR USE. DURING PREPARATION, THE CATHETER SURFACE WAS HYDRATED PRIOR TO REMOVAL FROM THE CARRIER HOOP. WHEN THE DEVICE WAS BEING REMOVED FROM THE HOUSING HOOP, IT WAS NOTED THAT THE CATHETER BROKE AT THE MIDWAY POINT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889203 ↗
• MalfunctionOct 4, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PART OF THE CATHETER PEELED OFF. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE IN THE LIVER. DURING UNPACKING, IT WAS NOTED THAT A PART OF IT PEELED OFF, NOT COVERED BY METAL COATING, WHICH COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872834 ↗
• MalfunctionOct 4, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FRACTURED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE CATHETER WAS KINKED, AND THE TIP OF THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872775 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A RENEGADE FATHOM-16 WAS SELECTED FOR USE. DURING PREPARATION, THE CATHETER SURFACED WAS HYDRATED PRIOR TO REMOVAL FROM THE CARRIER HOOP. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, IT WAS NOTED THAT THE CATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871675 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER AREA. A RENEGADE FATHOM-16 WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE DEVICE WAS FLUSHED, IT WAS NOTED THAT THE HUB WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840040 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS PARTIALLY FRACTURED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE IN RIGHT FEMORAL ARTERY PUNCTURE AND LEFT SUBCLAVIAN BRANCH ARTERY COIL EMBOLIZATION FOR FALSE ANEURYSM. DURING THE PROCEDURE, OUTSIDE THE PATIENT, THE CATHETER SURFACE WAS FLUSHED, AND THE CARRIER TUBE WAS HYDRATED PRIOR TO REMOVAL FROM CARRIER HOOP FOR ABOUT 1-2 SECONDS. THERE WAS NO RESISTANCE FELT UPON REMOVAL FROM THE HOOP. WHEN THE COIL WAS ABOUT TO BE DEPLOYED, IT WAS NOTED THAT THE OUTER MEMBRANE AT THE DISTAL END OF THE MICROCATHETER WAS PARTIALLY FRACTURED AND THE INNER CORE COULD BE SEEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17722147 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE LAYER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE LAYER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619976 ↗
• MalfunctionFeb 23, 2023Detachment of Device or Device Component; Material Integrity Problem; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE GOT FRACTURED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LIVER. A 180CM RENEGADE HI-FLO FATHOM SYSTEM-16 WAS SELECTED FOR USE. DURING THE PROCEDURE, A TENSION WAS FELT, THE TIP OF THE WIRE WAS SHEERED AND FRACTURED ON THE DISTAL TIP. THE WIRE WAS RETRIEVED THROUGH THE CATHETER AND THE ENTIRE SYSTEM WAS PULLED OUT ENTIRELY FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429464 ↗
• MalfunctionFeb 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE OUTER LAYER OF THE MICROCATHETER WAS DISLODGED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180CM RENHF 135CM 10 PRELOAD RENEGADE HI FLO WAS SELECTED FOR USE. AFTER UNPACKING THE INNER PACKAGE FOR HEPARIN WATER FLUSHING, IT WAS FOUND THAT THE OUTER LAYER OF THE MICROCATHETER WAS DISLODGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16413826 ↗
• MalfunctionDec 14, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29NOV2022. IT WAS REPORTED THAT THE MICROCATHETER COULD NOT CROSS THE IMAGING CATHETER AND WAS KINKED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180CM RENEGADE HI-FLO 16 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER SET COULD NOT CROSS THE IMAGING CATHETER. AFTER SEVERAL ATTEMPTS, THE DEVICE GOT KINKED, THEREFORE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE FRACTURED 40.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15981141 ↗
• MalfunctionAug 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE OUTER SHEATH WAS FLAKING. A 180CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE PHYSICIAN UNPACKED AND FLUSHED THE DEVICE, IT WAS NOTED THAT THE OUTER SHEATH FLAKING. 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 15294301 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT THE OUTER LAYER WAS DETACHED. A 180CM/135CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. PRIOR THE PROCEDURE, THE DEVICE WAS UNPACKED ACCORDING TO THE STANDARD PROCESS, HOWEVER THE OUTER LAYER WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598311 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. A 180CM/135CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE MIDDLE PART OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514094 ↗