Renegade™ M001182480Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729375395), received between May 26, 2020 and Apr 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE WIRE OCCURRED. A 105/3.0/2.5/.021/20/STRAIGHT RENEGADE MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT DURING TRACKING OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE LOCATED APPROXIMATELY 8.5CM FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048860 ↗
• MalfunctionDec 19, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A 105/3.0/2.5/.021/20 RENEGADE MICROCATHETER WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005181 ↗
• MalfunctionOct 14, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A 105/3.0/2.5/.021/20/STRAIGHT RENEGADE MICROCATHETER WAS SELECTED FOR USE IN THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT IS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611035 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKE. THE TARGET LESION WAS LOCATED IN THE LIVER. A 18 RENEGADE CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE UPON ADVANCING. THE DEVICE WAS PULLED OUT COMPLETELY FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411627 ↗
• MalfunctionMay 26, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2020. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE 50% STENOSED TARGET LESION WAS IN AN ACUTE ANGLED AND MODERATELY CALCIFIED RENAL ARTERY. A 105/3.0/2.5/.021/20 RENEGADE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION DUE TO THE GAP BETWEEN GUIDEWIRE AND MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED DEVICE SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088082 ↗