Renegade™ HI-FLO™ FATHOM™ System M001184570Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729790884), received between Nov 7, 2018 and Oct 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 19, 2022Break; Break

  IT WAS REPORTED THAT THE BLUE COATING OUTSIDE THE GUIDEWIRE WAS FRACTURED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS SOAKED IN SALINE AND HANDED IT TO THE PHYSICIAN. WHEN THE GUIDEWIRE WAS SLOWLY PULLED OUT, IT WAS NOTED THAT THE BLUE COATING OUTSIDE THE GUIDEWIRE 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 15446872 ↗
• InjuryJun 18, 2021Entrapment of Device; Fracture; Leak/Splash; Difficult to Remove; Difficult to Advance; Entrapment of Device; Fracture; Leak/Splash; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HEPATIC ARTERY (LIVER). A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT SINCE THE BEGINNING, THE PHYSICIAN COULD NOT CANNULATE SEVERAL ARTERIES WITH THIS MICROCATHETER. THE PHYSICIAN DETECTED THAT THE CATHETER WAS EXPERIENCING SOME DIFFICULTY IN ADVANCING AND RETRACTING. WHEN IT WAS REMOVED, THE CATHETER WAS FRACTURED. THE MICROCATHETER WAS PULLED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE KIT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE HEPATIC CHEMOEMBOLIZATION PROCEDURE HE IS UNDERGOING AS PART OF HIS ROUTINE CANCER TREATMENT. THE PATIENT WAS ADMITTED THE SAME DAY BEFORE THE PROCEDURE AND DUE TO THE FAILURE OF THE PROCEDURE (THE DOCTOR COULD NOT ACCESS THE AREA OF THE TUMOR HE WANTED TO EMBOLIZE), IT WAS NECESSARY FOR HIM TO SPEND THE NIGHT IN THE HOSPITAL. IT WAS DETECTED THAT THE RENEGADE MICROCATHETER WAS BRO

  Patient problems: Insufficient Information

  MAUDE report 12025336 ↗
• MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE SHEARED OFF. A 16 180CM X 150CM 20 PRELOAD RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. THE DEVICE WAS BEING PREPARED. HOWEVER, THE WIRE TIP SHEARED OFF WHILE TRYING TO SHAPE IT WITH AN INSERTION TOOL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558053 ↗
• MalfunctionOct 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP OF THE WIRE BROKE OFF. A 180CM/150CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF AND REMAINED IN THE CATHETER. THE DEVICE WAS COMPLETELY REMOVED AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE WIRE WAS THEN REPLACED WITH ANOTHER OF THE SAME SIZE AND COMPLETED THE PROCEDURE. NO COMPLICATIONS REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9255311 ↗
• MalfunctionSep 23, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SHEATHING STARTED COMING OFF ON THE CATHETER. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR A THROMBECTOMY PROCEDURE OF THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATHING STARTED STRIPPING OFF OF THE CATHETER. THE DEVICE WAS SIMPLY REMOVED OVER THE WIRE. NO DEVICE FRAGMENTS WERE LEFT INSIDE OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9105432 ↗
• MalfunctionNov 7, 2018Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18OCT2018. IT WAS REPORTED THAT THE TIP WAS KINKED AND DAMAGED. A 180CM/150CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS NOT ON ITS ORIGINAL SHAPE; TIP OF THE DEVICE WAS KINKED AND BENT IN DIFFERENT DIRECTIONS. IT WAS LIKE SOMEBODY HAD IT IN HIS HAND AND DEFORMED IT COMPLETELY, ONLY AT ITS TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MULTIPLE FRACTURES. IT WAS CONFIRMED THAT THE DEVICE WAS ALL IN THAT WAY (FRACTURED) WHEN OPENING THE PACKAGE DURING PREPARATION. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A RENEGADE HI-FLO MICRO-CATHETER. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THIS DEVICE WAS SEVERELY DAMAGED. THE DEVICE WAS FRACTURED IN 3 LOCATIONS. THE LOCATIONS OF THE FRACTURES WERE 12.4CM, 22.5CM AND 37.5CM FROM THE HUB. THE SHAFT WAS NOT COMPLETELY SEPARATED THE INNER LINER WAS STILL CONNECTED. THERE WERE MULTIPLE KINKS THROUGHOUT THE LENGTH OF THE CATHETER SHAFT. THE CATHETER SHAFT SHOWED THAT IT HAD BEEN STRETCHED. INS

  Patient problems: No Patient Involvement

  MAUDE report 8047044 ↗