Renegade™ M001182520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729235125), received between Mar 24, 2021 and Apr 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 130/20/1TIP RENEGADE MICROCATHETER WAS SELECTED FOR USE IN THE LIVER FOR A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. WHEN THE DEVICE WAS WITHDRAWN, IT WAS NOTED THAT THE COATING FELT A LITTLE BIT WRONG. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING PREPARATION. A KINK WAS OBSERVED ON THE DEVICE. WHEN REMOVED, THERE WAS A PEELING SECTION OF THE COATING ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928575 ↗
• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THAT BROKEN CATHETER OCCURRED. A 130/20 RENEGADE CATHETER-INFUSION WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT 1CM FROM THE DISTAL PART OF THE CATHETER GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17809418 ↗
• MalfunctionMar 24, 2021Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING PEELED OFF. THE TARGET LESION WAS LOCATED IN THE LIVER AREA. A RENEGADE WAS SELECTED FOR USE. DURING PROCEDURE, AFTER THE FIRST SESSION CHEMO DRUG INJECTION IN A LESION ANOTHER ARTERY SELECTION WAS PERFORMED. HOWEVER, THE DEVICE COULD NOT BE PUSHED AS THE POSITION OF THE RENEGADE IS JUST IN THE TIP OF THE RH CATHETER WHEN OBSERVED UNDER ANGIOGRAM BUT IT CAN'T BE PUSH OVER. BOTH CATHETER AND GUIDEWIRE WERE THEN REMOVED DIRECTLY FROM THE PATIENT'S BODY WITHOUT ANY FRICTION NOTED. UPON INSPECTION, THE CATHETER WAS ASTRINGENT TO TOUCH AS THE SURFACE WAS NOT SMOOTH, THUS IT WAS PRESUMED THAT THE HYDROPHILIC COATING OF RENEGADE CATHETER MIGHT BE PEELED OFF DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561068 ↗