Renegade™ M001182510Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729235118), received between Oct 19, 2018 and May 26, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Nonstandard Device

  IT WAS REPORTED THAT MICROCATHETER TIP FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A 150/10/1TIP RENEGADE FIBER BRAIDED WAS SELECTED FOR USE. PRIOR TO PROCEDURE, THE PLASTIC TRAY WAS BEING WITHDRAWN WHEN THE MICROCATHETER WAS NOTED TO BE DEFORMED, AND THE MICROCATHETER FRACTURED AT TIP AND TAIL ENDS DURING THE MICROCATHETER WAS COMPLETE WITHDRAWN. THE 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 25280450 ↗
• MalfunctionNov 21, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER INSIDE THE PACKAGE. A RENEGADE MICROCATHETER WAS SELECTED FOR USE IN THIS PROCEDURE. UPON OPENING THE PACKAGING WHILE STILL OUTSIDE THE PATIENT, THERE WAS WHAT APPEARED TO BE A HAIR INSIDE THE PACKAGE. THIS MICROCATHETER WAS NOT USED AND ANOTHER MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751111 ↗
• MalfunctionNov 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE COATING FLAKED OFF THE DEVICE. A 150CM RENEGADE WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY. DURING INSERTION OF THE RENEGADE THROUGH THE 5FR NON-BOSTON SCIENTIFIC CATHETER HUB, THE COATING FROM THE DISTAL END OF THE RENEGADE FLAKED OFF OUTSIDE THE PATIENT. A NEW 150CM RENEGADE WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820026 ↗
• MalfunctionNov 10, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE COATING FLAKED OFF THE DEVICE. A 150CM RENEGADE WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY. DURING INSERTION OF THE RENEGADE THROUGH THE 5FR NON-BOSTON SCIENTIFIC CATHETER HUB, THE COATING FROM THE DISTAL END OF THE RENEGADE FLAKED OFF OUTSIDE THE PATIENT. A NEW 150CM RENEGADE WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10819934 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A RENEGADE CATHETER WAS SELECTED FOR A PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURE. THE PATIENT HAD VERY DIFFICULT ANATOMY; IT WAS VERY ANGULATED AND STENOSED. DURING THE PROCEDURE, AFTER AN ATTEMPT OF A DYNA CT OVER THE HIGH PRESSURE SYRINGE, AN OVERVIEW SERIES WAS MADE. WHILE INJECTING, 3 ML OF CONTRAST WAS INJECTED WITH A 3ML SYRINGE FROM HAND. WHEN THE WIRE WENT THROUGH THE CATHETER, THE CATHETER SPLIT. WHEN THE CATHETER WAS PULLED OUT, IT WAS NOTED TO BE SPLIT INTO TWO PARTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428100 ↗
• MalfunctionOct 19, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT A WIRE PIERCED THROUGH THIS DEVICE. A RENEGADE MICROCATHETER WAS SELECTED FOR A PROSTATE ARTERY EMBOLIZATION (PAE) PROCEDURE. DURING THE PROCEDURE, A NON-BSC WIRE PIERCED THE RENEGADE CATHETER. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. RETURNED PRODUCT CONSISTED OF A RENEGADE HI-FLO MICRO-CATHETER WITH A .014 GUIDEWIRE PERFORATING THE SHAFT. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE PERFORATION WAS LOCATED 9CM FROM THE TIP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7984756 ↗