Renegade™ HI-FLO™ FATHOM™ System M001184550Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729790860), received between Nov 15, 2018 and Nov 12, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 17, 2023Fracture; Difficult to Remove; Difficult to Advance; Fracture; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE MID SHAFT OF THE DEVICE WAS FRACTURED. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING ADVANCING, THE PHYSICIAN FELT RESISTANCE WHEN MANIPULATING THE MICROCATHETER SO THE PHYSICIAN TRIED TO RETRACT IT, BUT IT WOULD NOT RETRACT MORE THAN ABOUT 10 CM. WHEN THE BASE CATHETER AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE MID SHAFT OF THE MICROCATHETER WAS FRACTURED. THE DETACHED PORTION OF THE DEVICE WAS REMOVED FROM THE BODY AND NO DEVICE FRAGMENTS WERE LEFT INSIDE THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161738 ↗
• MalfunctionFeb 9, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON 20JAN2022. IT WAS REPORTED THAT THE MICROCATHETER WAS KINKED AND CRACKED. A 180CM /135CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE MICROCATHETER WAS HIASCENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, ADDITIONAL INFORMATION REVEALED THAT THE MICROCATHETER HAS BEEN CRACKED. ALSO, IT WAS REPORTED THAT THE DEVICE WAS KINKED AND BUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497626 ↗
• MalfunctionNov 30, 2020Break; Failure to Advance; Material Integrity Problem; Break; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS SPLIT. THE ANATOMY WAS TORTUOUS. A 180CMX135CMX20 RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE BODY. THE CATHETER WAS DIFFICULT TO ASPIRATE AND THE WIRE WAS DIFFICULT TO ADVANCE OR RETRACT. UPON REMOVAL, THE CATHETER SEEMED TO BE SPLIT. THE DEVICE WAS REMOVED SAFELY WITH NO COMPLICATIONS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10920926 ↗
• MalfunctionAug 26, 2020Contamination; Use of Device Problem; Contamination; Use of Device Problem

  IT WAS REPORTED THAT THE SEAL WAS COMPROMISED. A 180CM/135CM RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE DEVICE HAD PASSED THE DEVICE DEADLINE AND THE SEAL WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10455120 ↗
• MalfunctionAug 25, 2020Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE CATHETER BROKE. A FATHOM 16X 180CM RENEGADE HI-FLO 135CMX20 WAS SELECTED FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. DURING PREPARATION, THERE WAS NOTED TO BE STRONG RESISTANCE WHEN REMOVING THE DEVICE FROM THE CARRIER HOOP AND THE MICROCATHETER BROKE IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449360 ↗
• MalfunctionAug 16, 2019Material Integrity Problem; Separation Problem; Material Integrity Problem; Separation Problem

  IT WAS REPORTED THAT THE TIP OF THE SHEATH WAS DISCONNECTED WITH THE TUBE. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USED. DURING PREPARATION, WHEN UNPACKING THE PLASTIC PACKAGE, IT WAS NOTED THAT A DISCONNECTION FROM THE TUBE OF THE TIP OF THE SHEATH AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT IS STABLE. NO COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8903888 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE TIP FRACTURE OCCURRED. THE TARGET AREA WAS LOCATED IN THE LATERAL FEMORAL ARTERY (LFA). A 180CM RENEGADE HI-FLO 135CM 20 PRELOAD FATHOM SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE COIL WAS DEPLOYED AND PUSHED FORWARD USING A GUIDEWIRE, IT WAS NOTED THAT THE WIRE HOOKED WITH THE COIL. FURTHERMORE, WHEN THE DEVICE WAS WITHDRAWN OUT OF THE PATIENT'S BODY WITHIN THE CATHETER, IT WAS FOUND OUT THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED. THE DEVICE WAS COMPLETELY REMOVED WITHIN THE CATHETER WITHOUT NEEDING ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316256 ↗
• MalfunctionJan 28, 2019Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-JAN-2019. IT WAS REPORTED THAT THE DEVICE WOULD NOT COME OUT OF THE PLASTIC HOOP. A RENEGADE HI-FLO FATHOM SYSTEM WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WOULD NOT COME OUT OF THE PLASTIC HOOP. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED ONE FRACTURE ON THE SHAFT LOCATED AT 34.5CM FROM THE HUB.

  Patient problems: No Patient Involvement

  MAUDE report 8282246 ↗
• MalfunctionNov 15, 2018Break; Difficult to Open or Remove Packaging Material; Material Integrity Problem; Break; Difficult to Open or Remove Packaging Material; Material Integrity Problem

  IT WAS REPORTED THAT THE BLUE COATING OF THE DEVICE WAS SEPARATED. A 180CM RENEGADE HI-FLO FATHOM SYSTEM CATHETER WAS SELECTED FOR USE. DURING PREPARATION, THE PRODUCT COULD NOT BE WITHDRAWN FROM THE PROTECTIVE CARRIER HOOP AND IT WAS FOUND OUT THAT THE BLUE COATING OF THE DEVICE HAD SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8074824 ↗