Renegade™ STC 18 M001181330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729444466), received between Dec 14, 2018 and May 14, 2025 — 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT CATHETER PERFORATION OCCURRED. A RENEGADE STC 18 CATHETER INFUSION WAS SELECTED FOR USE. DURING PROCEDURE, UPON GUIDEWIRE INSERTION, IT WAS NOTED THAT THE CATHETER WAS PUNCTURED AND BECAME UNUSABLE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021881 ↗
• MalfunctionOct 4, 2021Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A RENEGADE STC 18 INFUSION CATHETER WAS SELECTED FOR USE DURING A TRANS-ARTERIAL CHEMO EMBOLIZATION, IN THE ARTERIES OF THE LIVER. DURING THE PROCEDURE, IT WAS NOTED THAT THE RENEGADE STC BROKE WITHIN THE BASE CATHETER. THE PHYSICIAN HAD TO ENTIRELY REMOVE THE BASE CATHETER WITH THE BROKEN RENEGADE STC IN IT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REGAINING ACCESS WITH A BASE CATHETER AND ADVANCING A NON-BOSTON SCIENTIFIC MICROCATHETER FOR THE DELIVERY OF THE EMBOLIC BEADS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572755 ↗
• MalfunctionDec 14, 2018Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03-DEC-2018. A RENEGADE STC 18 WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY. HOWEVER, THE DEVICE WAS UNABLE TO BE ADVANCED TO THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS FOUND THE SHAFT WAS SEPARATED. DEVICE EVAL BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A RENEGADE STC-18 MICRO-CATHETER. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. UNDER MICROSCOPIC EVALUATION IT WAS NOTICED THAT THE DEVICE LOOKED TO BE CUT/DETACHED/SEPARATED AT THE TIP AREA. THE DEVICE WAS MEASURED AND THERE WAS APPROXIMATELY 16CM OF THE DEVICE MISSING FROM THE TIP END. THE DEVICE SHOULD MEASURE 130CM LONG. THE ACTUAL MEASURED DEVICE WAS 114CM. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. A .014 THRUWAY TEST GUIDEWIRE WAS INSERTED INTO THE DEVICE AND THE WIRE TRANSCENDED THROUGH THE LUMEN WITH NO HESITATIONS OR RESTRICTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8164480 ↗