Renegade HI-FLO FATHOM SystemRecalls & reported problems across all models
Boston Scientific Corporation · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 74
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 7 models of Renegade HI-FLO FATHOM System by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2018 and Sep 18, 2026 — classified as 2 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Break” (28 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 FATHOM System problems
Device problems
- Break28
- Material Integrity Problem16
- Detachment of Device or Device Component10
- Fracture8
- Adverse Event Without Identified Device or Use Problem7
- Difficult to Open or Remove Packaging Material7
- Difficult to Advance5
- Difficult to Remove4
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient19
- No Patient Involvement15
- Foreign Body In Patient2
- Insufficient Information1
Renegade HI-FLO FATHOM System models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Renegade™ HI-FLO™ FATHOM™ System M001184540Catheter, continuous flush44 reports
- Renegade™ HI-FLO™ FATHOM™ System M001184550Catheter, continuous flush11 reports
- Renegade™ HI-FLO™ FATHOM™ System M001184560Catheter, continuous flush8 reports
- Renegade™ HI-FLO™ FATHOM™ System M001184570Catheter, continuous flush8 reports
- Renegade™ HI-FLO™ FATHOM™ System M001184500Catheter, continuous flush1 report
- Renegade™ HI-FLO™ FATHOM™ System M001184520Catheter, continuous flush1 report
- Renegade™ HI-FLO™ FATHOM™ System M001184530Catheter, continuous flush1 report
Recent Renegade HI-FLO FATHOM System adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionNov 12, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT SHAFT OBSTRUCTION OCCURRED. A RENEGADE HI FLO WAS SELECTED FOR TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION. DURING THE PROCEDURE, AFTER THE EMBOLIC PARTICLE WAS INJECTED, ANOTHER TARGETED BLOOD VESSEL WAS SELECTED TO INJECT THE EMBOLIC PARTICLE AGAIN, RESULTING IN A BLOCKED CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED SHAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536075 ↗MalfunctionOct 24, 2025Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DETACHMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. A 16 180CM RENHF 135CM 20 PRELOAD FATHOM WAS SELECTED FOR USE. DURING THE PREPARATION, THE CATHETER APPEARED FRAYED AT THE TIP UPON OPENING OF THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381328 ↗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 ↗MalfunctionOct 15, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE BLUE COATING OUTSIDE THE GUIDEWIRE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180CM RENHF 150CM 20 PRELOAD RENEGADE HI-FLO FATHOM 16 SYSTEM WAS SELECTED FOR PERCUTANEOUS SELECTIVE HEPATIC ARTERIOGRAPHY, LOCAL CHEMOTHERAPY AND ARTERIAL EMBOLIZATION. DURING THE PROCEDURE, WHEN THE PACKAGE WAS OPENED AND HANDED THE DEVICE TO THE PHYSICIAN AFTER SOAKING IT IN NORMAL SALINE, THE PHYSICIAN SLOWLY PULLED OUT THE GUIDEWIRE AND NOTED THAT THE BLUE COATING OUTSIDE THE GUIDEWIRE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291700 ↗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 12, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED INTERNALLY. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE WITHIN THE MODERATELY TORTUOUS RIGHT INTERNAL ILIAC - GLUTEUS BRANCH. DURING THE PROCEDURE, APPROXIMATELY 3 CM OF THE DISTAL SEGMENT OF THE GUIDEWIRE FRACTURED WITHIN THE PATIENT. THE DEVICE DEFICIENCY WAS DEEMED NON-CONSEQUENTIAL TO THE PATIENT CONDITION. THERE WERE NO IMMEDIATELY REPORTED PATIENT COMPLICATIONS. NO FURTHER DETAILS WERE PROVIDED REGARDING THE PROCEDURE OUTCOME OR PATIENT STATUS, DESPITE REQUEST BY BOSTON SCIENTIFIC.
Patient problems: Foreign Body In Patient
MAUDE report 20669806 ↗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 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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