Renegade HI-FLO KitRecalls & reported problems across all models
Boston Scientific Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of Renegade HI-FLO Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2018 and Aug 18, 2026 — classified as 2 injuries, 139 malfunctions.
The most frequently reported specific device problem is “Break” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Renegade HI-FLO Kit problems
Device problems
- Break68
- Fracture20
- Material Integrity Problem15
- Detachment of Device or Device Component13
- Entrapment of Device10
- Adverse Event Without Identified Device or Use Problem7
- Difficult to Advance7
- Difficult to Open or Remove Packaging Material7
Patient problems
- No Clinical Signs, Symptoms or Conditions69
- No Consequences Or Impact To Patient55
- No Patient Involvement15
- Device Embedded In Tissue or Plaque2
- No Code Available1
- No Known Impact Or Consequence To Patient1
Renegade HI-FLO Kit models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Renegade™ HI-FLO™ Kit M001183020Catheter, continuous flush109 reports
- Renegade™ HI-FLO™ Kit M001183030Catheter, continuous flush28 reports
- Renegade™ HI-FLO™ Kit M001183010Catheter, continuous flush2 reports
- Renegade™ HI-FLO™ Kit M001182980Catheter, continuous flush1 report
- Renegade™ HI-FLO™ Kit M001182990Catheter, continuous flush1 report
Recent Renegade HI-FLO Kit adverse event reports
The 15 most recent reports across all models, 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 26, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 135/20 RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR USE IN A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION TO TREAT LIVER CANCER. DURING PREPARATION, THE TIP OF THE CATHETER WAS COMPLETELY SEPARATED. 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 24177623 ↗MalfunctionJan 14, 2026Obstruction of Flow; Material Integrity Problem
IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROSTATE ARTERY. A 115/20 KIT RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE WIRE IN THE CATHETER HAD BEEN NAVIGATED TO THE INTENDED LOCATION. HOWEVER, THE COATING FROM THE WIRE CAUSED THE CATHETER TO BECOME CLOGGED, PREVENTING ANYTHING FROM PASSING THROUGH. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND 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 24075015 ↗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 ↗MalfunctionAug 21, 2025Break; Break
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 115/20 RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INSERTION INTO THE PATIENT, IT WAS NOTED THAT THE MICROCATHETER SNAPPED NEAR THE HUB. THE FRACTURE OCCURRED AT A PORTION OF THE DEVICE OUTSIDE OF THE PATIENT'S BODY, AND THE DEVICE WAS REMOVED INTACT AND IN ONE PIECE WITHOUT REQUIRING ANY ADDITIONAL RETRIEVAL METHODS. BECAUSE THERE WAS NO BACKUP CATHETER AVAILABLE, THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859734 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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