Renegade™ HI-FLO™ M001182890Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729280644), received between Jan 22, 2019 and May 8, 2026 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED THAT A MICROCATHETER FRACTURE OCCURRED. A 135/20 RENEGADE HI FLO MICROCATHETER WAS ADVANCED FOR USE IN A MALIGNANT NEOPLASM OF THE RECTUM. NO FRACTURE WAS OBSERVED UPON OPENING THE PACKAGE OR INITIAL INSPECTION. HOWEVER, A FRACTURE WAS IDENTIFIED APPROXIMATELY 10 CM AFTER VASCULAR ENTRY DURING THE PROCEDURE. THE DEVICE WAS SUBSEQUENTLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25130932 ↗
• MalfunctionJun 9, 2025Break; Entrapment of Device; Material Rupture; Break; Entrapment of Device; Material Rupture

  IT WAS REPORTED THAT THE DEVICE STUCK IN SHEATH AND RUPTURED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE RUPTURED UPON WITHDRAWAL. THIS MAY HAVE BEEN TO INADEQUATE FLUSHING, WHICH POTENTIALLY LED TO THE DEVICE BECOMING LODGED WITHIN THE SHEATH, RESULTING IN DEVICE RUPTURE. THE PROCEDURE WAS COMPLETED USING 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 22170856 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS IN THE LIVER. A RENEGADE HI FLO 135/20 WAS UNPACKED. HOWEVER, WHEN THE MICROCATHETER WAS PULLED OUT FROM THE PROTECTOR SHEATH, IT WAS FOUND FRACTURED, YET IS STILL INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331177 ↗
• MalfunctionSep 22, 2023Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31 AUG 2023. IT WAS REPORTED THAT THE MICROCATHETER WAS BENT AND KINKED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR UTERINE ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS BENT AND KINKED INSIDE THE PATIENT'S BODY. 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 18.5CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17799255 ↗
• MalfunctionSep 7, 2022Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE MICROCATHETER BECAME STUCK INSIDE THE CATHETER DURING ADVANCING. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE IN THE LIVER. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER BECAME STUCK INSIDE THE CATHETER DURING ADVANCING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS SEPARATION LOCATED AT 94CM FROM THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370140 ↗
• MalfunctionAug 24, 2022Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 01AUG2022. IT WAS REPORTED THAT A MICRO-CATHETER WAS STUCK. A 135/20 RENEGADE HI-FLO SELECTED FOR USE IN A PERCUTANEOUS SELECTIVE ARTERIAL EMBOLIZATION IN THE LIVER. DURING ADVANCEMENT, THE DEVICE WAS STUCK INTO THE 4F IMAGE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, THE DEVICE INVESTIGATION REVEALED A PIECE OF THE TIP (APPROXIMATELY 1MM) DETACHED AND NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289278 ↗
• InjuryJul 26, 2022Leak/Splash; Material Integrity Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT THE MICROCATHETER BROKE WHICH LEADS TO PATIENT'S DRUG DOSES FALLING SHORT OF MEDICAL PRESCRIPTIONS. A 135/20 RENEGADE HI-FLO CATHETER-INFUSION WAS USED IN THE CONTINUOUS TRANSCATHETER HEPATIC ARTERY DRUG DELIVERY FOR HEPATOCELLULAR CARCINOMA. DURING USAGE, IT WAS NOTED THAT THE MICROCATHETER WAS DAMAGED AND LEAKING RESULTING IN PATIENT'S DRUG DOSES FALLING SHORT OF MEDICAL PRESCRIPTIONS. THE SPECIFIC LOST DRUG DOSE COULD NOT BE ASSESSED. THE MICROCATHETER WAS REMOVED AND A SPARE LARGE CATHETER WAS USED TO ADMINISTER THE DRUG. THERE WERE NO OBVIOUS SIGNS OF HARM AND THE PATIENT WAS UNDER FURTHER OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108664 ↗
• MalfunctionJul 15, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB VENOUS. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PREP FOR THE PROCEDURE, IT WAS NOTED THAT THE DEVICE FRACTURED IN THE MIDDLE OF CATHETER WHEN PULLED FROM THE PROTECTIVE SHEATH AFTER FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15031122 ↗
• MalfunctionMay 16, 2022Contamination; Unsealed Device Packaging; Contamination; Unsealed Device Packaging

  IT WAS REPORTED THAT A DEVICE CONTAMINATION OCCURRED. A 135/20 RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGING WAS NOT SEALED AND THE STERILITY OF THE DEVICE WAS COMPROMISED. 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 14408855 ↗
• MalfunctionMar 31, 2022Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON UNPACKING, IT WAS NOTED THAT THE BODY OF THE MICROCATHETER WAS ASTRINGENT, NOT AS SMOOTH AS THE ONE USED BEFORE. IT IS VERY LIKELY TO BE KINKED WHEN DELIVERED INSIDE THE PATIENT ALONG THE WIRE DURING THE PROCEDURE. THE MICROCATHETER COULD NOT BE WITHDRAWN FROM THE CATHETER AND IT WAS NOTED THAT THE DEVICE WAS FRACTURED AT THE MIDDLE OF THE CATHETER. THE DEVICE WAS NOT USED IN PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967010 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY PUNCTURE. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICROCATHETER WAS FRACTURED INSIDE THE HEPATIC ARTERY. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT AND NO COMPLICATIONS REPORTED. PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934366 ↗
• InjuryJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP MARKER FELL AND REMAINED IN THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP MARKER FELL OFF AND FLOWED IN THE DISTAL CORONARY ARTERY WHEN THE WIRE WAS LOADED. CONSEQUENTLY, THE FRAGMENT WAS PUSHED/FIXED TOWARDS THE PERIPHERY OF THE VESSEL. IT WAS THOUGHT THAT IT WAS CAUGHT BY THE Y CONNECTOR WHEN THE MICROCATHETER WAS PULLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12230257 ↗
• MalfunctionDec 2, 2020Difficult to Insert; Stretched; Difficult to Insert; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2020. IT WAS REPORTED THAT DEVICE STUCK AND STRETCHED FROM HUB TOWARDS THE TIP. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERY. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK WHEN CROSSING THROUGH THE 4F NON-BOSTON SCIENTIFIC SHEATH. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND NOTED TO HAVE STRETCHED FROM THE HUB 15CM TOWARDS THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED OUTER SHAFT SEPARATION AT 18.7CM FROM THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936623 ↗
• MalfunctionOct 26, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING PEELED OFF. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, RESISTANCE WAS FELT UPON PULLING THE DEVICE OUT FROM THE DISPENSER. SUBSEQUENTLY, IT WAS NOTED THAT THE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10733656 ↗
• MalfunctionOct 16, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE LIVER WITH LESS THAN 40% TORTUOUSITY. DURING PROCEDURE, A RENEGADE HI-FLO WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689774 ↗
• MalfunctionNov 18, 2019Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28 OCT 2019. IT WAS REPORTED THAT THE CATHETER HAD LUMEN ISSUE. THE TARGET LESION WAS LOCATED IN BRONCHIAL ARTERY. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER LUMEN HAD ISSUES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE OUTER SHAFT SEPARATED AT 32CM FROM THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335038 ↗
• MalfunctionNov 18, 2019Break; Break

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. A 135/20 RENEGADE HI-FLO WAS SELECTED FOR A UTERINE FIBROID EMBOLIZATION (UFE) PROCEDURE. DURING PREPARATION, THE DEVICE GOT SEPARATED WHEN TRYING TO REMOVE IT FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335000 ↗
• MalfunctionOct 3, 2019Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13SEP2019. IT WAS REPORTED THAT DEVICE WAS STUCK IN CATHETER. A 135/20 RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, RESISTANCE WAS NOTED AND THE DEVICE GOT STUCK AT THE 4FR NON-BSC CONTRAST CATHETER LUMEN. INTERMITTENT FLUSHING WAS PERFORMED. THE CATHETER SURFACE WAS FLUSHED AND THE CARRIER TUBE WAS HYDRATED PRIOR TO REMOVAL FROM CARRIER HOOP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME RENEGADE AND NO RESISTANCE WAS FELT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE OUTER SHAFT WAS SEPARATED 44CM FROM THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152825 ↗
• MalfunctionJan 22, 2019Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08 JAN 2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 135/20 RENEGADE HI-FLO MICRO-CATHETER WAS ADVANCED FOR A LIVER CANCER PROCEDURE BUT FAILED TO CROSS TO AN 5F IMAGING CATHETER . THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED. THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267369 ↗