Renegade™ HI-FLO™ Kit M001183020Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 08714729280774), received between Aug 9, 2018 and Aug 18, 2026 — classified as 2 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304656 ↗
• MalfunctionMay 20, 2026Break; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A GUIDEWIRE SEPARATION OCCURRED. THE PATIENT UNDERWENT A UTERINE ARTERY EMBOLIZATION PROCEDURE FOR TREATMENT OF ADENOMYOSIS/HYSTEROMYOMA. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED UTERINE ARTERY. A 135/10 RENEGADE HI-FLO KIT MICROCATHETER WAS USED FOR A SUPER-SELECTIVE UTERINE ARTERY PROCEDURE. AFTER FLUSHING WITH NORMAL SALINE, THE CATHETER COULD NOT BE WITHDRAWN SMOOTHLY. DURING WITHDRAWAL, THE GUIDEWIRE FRACTURED AND SEPARATED WITHIN THE CATHETER. THE DISTAL TIP OF THE GUIDEWIRE COULD NOT BE REMOVED, AND THE CATHETER COULD NO LONGER BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234086 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16MAR2026. IT WAS REPORTED THAT DEVICE LEAK OCCURRED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN THE LIVER. DURING PREPARATION, IT WAS NOTED THAT THE CONNECTION BETWEEN THE MICROCATHETER AND THE SYRINGE WAS LEAKING LIQUID AND COULD NOT CONTINUE TO PUMP THE DRUG. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED AN OUTER SHAFT LINER FRACTURE LOCATED APPROXIMATELY 6CM FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823966 ↗
• MalfunctionMar 31, 2026Fluid/Blood Leak; Material Rupture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT MICROCATHETER RUPTURED OCCURRED. A 135/10 RENEGADE HI-FLO MICROCATHETER WAS SELECTED FOR TRANSCATHETER HEPATIC ARTERY EMBOLIZATION. ROUTINE SURGICAL SETUP AND DRAPING WERE PERFORMED. THE MICROCATHETER WAS UNPACKED, PREPARED, AND FLUSHED. DURING FLUSHING, LEAKAGE WAS OBSERVED FROM THE MIDDLE MICROCATHETER. FURTHER INSPECTION REVEALED KINKING AND DAMAGE ALONG THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743194 ↗
• MalfunctionFeb 24, 2026Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A 135/10 KIT RENEGADE HI FLO WAS SELECTED FOR USE. PRIOR TO PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS KINKED AND FRACTURED. 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 24430125 ↗
• MalfunctionJan 8, 2026Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE LIVER. A 135/10 RENEGADE HI FLO KIT WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE MICROCATHETER COULD NOT BE USED NORMALLY AND WAS DIFFICULT TO REMOVE FROM THE HEPATIC DUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE MICROCATHETER GOT STUCK BY THE ANGIOGRAPHIC CATHETER AND COULD NOT BE PULLED OUT. THE DEVICE WAS REMOVED TOGETHER WITH THE ANGIOGRAPHIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24015177 ↗
• MalfunctionJan 7, 2026Nonstandard Device

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A 135/10 KIT RENEGADE HI FLO WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED. 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 23995907 ↗
• MalfunctionDec 15, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 135/10 RENEGADE HI FLO KIT WAS SELECTED FOR USE IN THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). DURING THE PROCEDURE, THE MICROCATHETER COULD NOT BE USED NORMALLY AND COULD NOT BE RETRACTED FROM THE HEPATIC DUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803437 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE STENOSED TARGET LESION WAS IDENTIFIED WITHIN A MALIGNANT TUMOR IN THE LIVER. A RENEGADE HI-FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, DEVICE WAS FRACTURED WHEN BEING WITHDRAWN AND WAS NOT IMPLANTED INTO THE BODY. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756899 ↗
• MalfunctionNov 12, 2025Degraded; Degraded

  IT WAS REPORTED THAT A COATING ISSUE ON THE CATHETER OCCURRED. A 135/10 RENEGADE HI FLO WAS SELECTED FOR USE IN A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). UPON UNPACKING, IT WAS DISCOVERED THAT TWO SECTIONS OF THE CATHETER LACKED COATING AND COULD NOT BE USED. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534444 ↗
• MalfunctionSep 25, 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 GUIDEWIRE STUCK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. A RENEGADE HI FLO 135/10 KIT WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE PATIENT, THE GUIDEWIRE WAS STUCK AND COULD NOT BE PULLED OUT. THE DEVICE DID NOT ENTER THE PATIENT, AND 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 23151504 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Integrity Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT MICROCATHETER RUPTURED OCCURRED. A 135/10 RENEGADE HI FLO WAS SELECTED FOR LIVER CANCER RUPTURE EMBOLIZATION. DURING THE PROCEDURE, THE MICROCATHETER RUPTURED WHEN IT BECAME TWISTED. 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 22555457 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. IT WAS REPORTED THAT THE PATIENT UNDERWENT HEPATIC ARTERY CATHETERIZATION FOR PERFUSION CHEMOTHERAPY. A 135/10 RENEGADE HI FLO KIT WAS SELECTED FOR USE. DURING PREPARATION FOR THE PROCEDURE, THE PACKAGE WAS OPENED, AND THE CATHETER WAS FLUSHED, AFTER WHICH IT WAS NOTED THAT THE TIP WAS DETACHED FROM THE MICROCATHETER BODY, AND THE INNER BRAIDED WIRE WAS EXPOSED. 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 22341540 ↗
• MalfunctionOct 24, 2024Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A RENEGADE HI FLO 135/10 KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PRE-PACKAGED GUIDEWIRE COULD NOT BE ADVANCED, AND THEN DISCOVERED THAT IT WAS FRACTURED. THE DEVICE WAS REMOVED, AND 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 20526048 ↗
• MalfunctionOct 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER VESSEL. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR INTERVENTIONAL EMBOLIZATION FOR LIVER CANCER. HOWEVER, AFTER UNPACKING, IT WAS FOUND THAT THE MICROGUIDEWIRE AND THE MICROCATHETER COULD NOT BE REMOVED FROM THE PROTECTIVE SHEATH. CONSEQUENTLY, THE MICROGUIDEWIRE WAS FRACTURED AFTER SEVERAL ATTEMPTS TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523647 ↗
• MalfunctionSep 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN THE LIVER. DURING UNPACKING, IT WAS NOTED THAT A SECTION OF GUIDEWIRE HAD NO COATING. 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 20152262 ↗
• MalfunctionJul 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING DETACHED. A 135/10 KIT RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR TREATMENT. DURING PREPARATION, IT WAS FOUND THAT THE BLUE COATING WAS FRACTURED WHEN THE MICROCATHETER WAS PULLED OUT. DUE TO THIS, THE GUIDEWIRE IN THE MICROCATHETER WAS MESSY AND STRETCHED. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817442 ↗
• MalfunctionJul 11, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE LIVER. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE). HOWEVER, AFTER FLUSHING WITH NORMAL SALINE, IT WAS NOTED THAT THE SURFACE OF HYDROPHILIC COTING WAS ROUGH, AND THE DEVICE COULD NOT CROSS THE 5F IMAGING CATHETER TO THE LESION. 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 19723914 ↗
• MalfunctionMay 30, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR TREATMENT, BUT IT WAS UNABLE TO LET OTHER DEVICES CROSS. BASED ON THE RECEIVED PHOTO OF THE COMPLAINT DEVICE, IT WAS NOTED THAT THE SHAFT WAS BROKEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19430715 ↗
• MalfunctionApr 11, 2024Entrapment of Device; Material Integrity Problem; Positioning Problem; Entrapment of Device; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN A RIGHT HEPATIC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS STUCK. WHEN THE MICROCATHETER WAS WITHDRAWN, A MARK OF BEING KINKED WAS NOTED AT THE TIP OF THE MICROCATHETER. 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 19093377 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR HEPATIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS BROKEN AFTER ENTERING THE PATIENT. THE DEVICE WAS SIMPLY PULLED OUT AND 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 19028583 ↗
• MalfunctionJan 30, 2024Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE CATHETER HAD DAMAGED DURING UNPACKING. A 135/10 RENEGADE HI-FLO KIT WAS SELECTED FOR HEPATIC ARTERIAL CHEMOEMBOLIZATION. DURING UNPACKING, IT WAS NOTED THAT THE CATHETER HAD DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A FRACTURE LOCATED 23.7CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608945 ↗
• MalfunctionDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT RADIAL ARTERY. A 135/10 RENEGADE HI-FLO KIT WITH FATHOM GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE LESION WAS EMBOLIZED WITH A MICROCATHETER, AND THE FRONT PART OF THE GUIDEWIRE EQUIPPED WITH THE MICROCATHETER WAS SHAPED BEFORE SUPERSELECTIVE INTUBATION OF THE LEFT UTERINE ARTERY. HOWEVER, IT WAS NOTED THAT THE FRONT PART OF THE GUIDEWIRE WAS FRACTURED, AND THE TIP WAS NOT COMPLETELY SEPARATED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT RECOVERED WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303978 ↗
• MalfunctionSep 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. A RENEGADE HI-FLO KIT WAS SELECTED FOR USE IN THE LIVER. DURING UNPACKING, THE CATHETER SURFACE WAS FLUSHED/ CARRIER TUBE WAS HYDRATED PRIOR TO REMOVAL FROM CARRIER HOOP FOR 5 MINUTES. A RESISTANCE WAS FELT DURING CATHETER REMOVAL AND RE-FLUSHING WITH SALINE WAS DONE. HOWEVER, IT WAS NOTED THAT THE PROXIMAL END WAS FRACTURED AND COULD NOT BE USED ANYMORE. 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 17749320 ↗
• MalfunctionSep 13, 2023Break; Break

  IT WAS REPORTED THAT MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. THE BLOOD VESSELS OF THE ANATOMICAL STRUCTURE HAVE MORE SMALL CURVES, AND THE BLOOD VESSELS OF THE ABDOMINAL TRUNK AND COMMON HEPATIC ARTERY ARE "U" SHAPE. A 135/10 RENEGADE HI FLO KIT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE TIP GOT FRACTURED AT THE PROXIMAL END, THE CONNECTION BETWEEN THE HUB AND THE MICROCATHETER AND COULD NOT BE USED ANY LONGER. 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 17741320 ↗