Renegade™ HI-FLO™ M001182900Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729280651), received between May 22, 2019 and Feb 25, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. THE STENOSED TARGE LESION WAS LOCATED IN THE RENAL ARTERY. A RENEGADE? HI-FLO? CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, DURING THE PROCEDURE, THE CATHETER LUMEN WAS REPORTED TO BE DEFORMED, WHICH CAUSED THE GUIDEWIRE TO BECOME STUCK. 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 24444219 ↗
• MalfunctionFeb 18, 2026Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SPLENIC ARTERY. A 150/10 RENEGADE HI FLO AND 165CM TRANSEND 18 GUIDEWIRE WERE SELECTED FOR EMBOLIZATION. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). HOWEVER, DURING ADVANCEMENT, IT WAS NOTED THAT THE DEVICES BECAME STUCK WITH THE 0.038 NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER AND COULD NOT BE PULLED OUT. THE DEVICES WERE THEN PULLED OUT DIRECTLY AND 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 24384072 ↗
• MalfunctionNov 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED REMOVAL DIFFICULTY OCCURRED. THE 20% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED LIVER. A 150/10 RENEGADE HI FLO WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE MICROCATHETER BECAME STUCK IN THE HEPATIC DUCT AND COULD NOT GET OUT. THE DEVICE WAS REMOVED NORMALLY WITHOUT USING ADDITIONAL DEVICES. AND 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 23649089 ↗
• MalfunctionNov 21, 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 THE MICROCATHETER AND GUIDEWIRE BECAME ENTRAPPED. A RENEGADE? HI-FLO? MICROCATHETER AND A 0.016" FATHOM? GUIDEWIRE WERE SELECTED FOR USE IN A PROCEDURE. IT WAS NOTED THAT THE GUIDEWIRE BECAME STUCK IN THE MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617022 ↗
• MalfunctionSep 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS THE HEPATIC ARTERY. A 150/10 RENEGADE HI-FLO MICROCATHETER WAS SELECTED FOR USE FOR A Y-90 EMBOLIZATION IN THE HEPATIC ARTERY. DURING PREPARATION, THE SCRUB TECH NOTICED THAT THE OUTER COATING WAS COMING OFF OF THE MICROCATHETER. THE ITEM WAS NOT USED AND REMOVED FROM THE STERILE FIELD. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23051355 ↗
• MalfunctionSep 12, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS COMPLETELY BROKEN. A 150/10 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, PROTECTION TUBE WAS IRRIGATED, HOWEVER, A COMPLETE BREAK OF THE CATHETER WAS NOTED UPON RETRIEVING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15404187 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS DETACHED. A 150/10 RENEGADE HI-FLO CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, A MICROCATHETER WAS OPEN FOR SUPER-SELECTION OF BLOOD VESSELS, BUT THE DEVICE COULD NOT BE USED, THE DEVICE WAS DETACHED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122035 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A 150/10 RENEGADE HI-FLO CATHETER INFUSION WAS SELECTED FOR USE FOR A UTERINE FIBROID EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RENEGADE FELT A BIT TIGHT ON THE 4FR NON BSC GUIDE CATHETER. THE PHYSICIAN WAS ABLE TO COMPLETE THE INTERVENTION; HOWEVER, DURING REMOVAL OF THE CATHETER, IT WAS NOTED THAT FURTHER TIGHTNESS WAS EXPERIENCED AND THE RENEGADE BEGAN TO BREAK AND UNRAVEL. THE DEVICE WAS COMPLETELY REMOVED WITH THE NON BSC GUIDE CATHETER FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632590 ↗