Renegade™ HI-FLO™ M001182910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729280668), received between Dec 14, 2022 and Feb 26, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionFeb 26, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A 150/20 RENEGADE HI FLO AND A .014/190CM GW TRANSEND PERIPH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE RENEGADE AND TRANSCEND DEVICES WERE UNABLE TO ADVANCE THROUGH A 5F GUIDE CATHETER AT THE PROXIMAL END, JUST BEYOND THE HUB. A NEW GUIDE WAS ATTEMPTED, BUT THE SAME ISSUE OCCURRED WITH THE FIRST RENEGADE AND TRANSCEND. NEW RENEGADE AND TRANSCEND DEVICES WERE THEN OPENED AND ADVANCES TO THE TIP OF THE 5F GUIDE, THE RENEGADE WOULD NOT ADVANCE OUT THE TIP OF THE GUIDE. IT WAS NOTED THAT THERE WERE GRITTINESS AND FRICTION DURING INSERTION AND REMOVAL. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456304 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN. A RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. WHILE OPENING THE DEVICE PACKAGE AND REMOVING THE DEVICE, THE CATHETER BROKE. ANOTHER RENEGADE HI-FLO CATHETER WAS SELECTED FOR USE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819858 ↗
• MalfunctionDec 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A RENEGADE HI-FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE WRAPPER, IT WAS NOTED THAT A SMALL FOREIGN OBJECT WAS FOUND IN THE HUB PART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983642 ↗