Renegade™ STC 18 M001181370Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729444503), received between Jul 10, 2020 and May 23, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 18, 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.

• InjuryMay 23, 2022Mechanical Problem; Failure to Advance; Mechanical Problem; Failure to Advance

  IT WAS REPORTED THAT THERE WAS CLAMPING OF THE PROXIMAL LEFT BRONCHIAL ARTERY AND ARTERIAL OCCLUSION. THE TARGET LESION WAS LOCATED IN THE BRONCHIAL ARTERY. A 150/20 RENEGADE STC 18 CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, A SUPER SELECTION WAS PERFORMED WITH A MICROGUIDE WIRE AND A MICROCATHETER. THE MICROGUIDE ENTER IN THE LEFT BRONCHIAL ARTERY HOWEVER, THE ANGLE OF THE VESSEL WAS LARGE AND THE MICROCATHETER WAS TOO STIFF TO FOLLOW UP. SEVERAL ATTEMPTS WERE MADE, BUT A FORMATION OF CLAMPING IN THE PROXIMAL LEFT BRONCHIAL ARTERY AND ARTERIAL OCCLUSION OCCURRED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE POST PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14476514 ↗
• MalfunctionFeb 17, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT SPLENIC ARTERY EMBOLIZATION UNDER LOCAL ANESTHESIA. THE PATIENT WAS PLACED IN A LYING POSITION, WAS PLACED REGULAR DISINFECTING TOWEL, THE RIGHT INGUINAL REGION WAS LOCAL ANESTHETIZED WITH 5 ML OF 2% LIDOCAINE, THE RIGHT FEMORAL ARTERY WAS PUNCTURED, THE 5F VASCULAR SHEATH WAS PLACED THROUGH THE FEMORAL ARTERY. A .014/190CM GW TRANSEND PERIPH AND 150/20/STRAIGHT/1RO RENEGADE STC-18 INFUSION CATHETERS WERE DELIVERED TO THE BIFURCATION OF THE ILIAC ARTERY. THE STC MICROCATHETER WAS DISASSEMBLED, AND THE SHEATH WAS REMOVED. THE MICROCATHETER WAS FLUSHED WITH 10 CC OF SALINE IN BOTH DIRECTIONS AND THE MICROCATHETER WAS REMOVED. THE MICROCATHETER WAS FOUND TO BE DEFORMED AND FRACTURED, AND WAS UNABLE TO BE USED NORMALLY, AND THERE WAS DIFFICULTY IN ADVANCING THE WIRE INSIDE THE CATHETER, SO A NEW SET OF STC MICROCATHETER AND TRANSEND COMBINATION WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552620 ↗
• MalfunctionJul 20, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2021. IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT GO FORWARD. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A RENEGADE STC 18 CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER REACHING THE MAIN SPLENIC ARTERY, THE RENEGADE MICROCATHETER WAS FLUSHED AND TAKEN OUT. A 0.014 NON BOSTON SCIENTIFIC GUIDEWIRE WAS THEN INSERTED ALONG WITH THE CATHETER; HOWEVER AFTER REACHING THE MIDDLE OF THE MICROCATHETER, THE GUIDEWIRE COULD NOT GO FORWARD. REPEATED ATTEMPTS ALL FAILED AND REPLACEMENT OF A GUIDEWIRE STILL COULD NOT WORK. THE MICROCATHETER WAS NOT BENT OR BROKEN AFTER CHECKING AND A NEW 2.4F MICROCATHETER WAS UNPACKED AND THE SAME GUIDEWIRE COULD CROSS SUCCESSFULLY. LASTLY, THE COIL WAS DEPLOYED SUCCESSFULLY WITH THE NEW MICROCATHETER FOR EMBOLIZATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS FINE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A SMALL PIECE OF THE INNER LINER WAS DISLODGED AND CAME OUT THE END WITH THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197084 ↗
• MalfunctionSep 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURED UPON WITHDRAWAL DURING UNPACKING. A RENEGADE STC 18 WAS SELECTED FOR USE. UPON UNPACKING, THE DEVICE WAS IMMERSED IN THE SALINE SOLUTION, HOWEVER THE TIP OF THE MICROCATHETER WAS FRACTURED WHEN WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587198 ↗
• MalfunctionJul 10, 2020Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JUN2020. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS LESION. THE TARGET LESION WAS LOCATED IN THE 60% TORTUOUS SPLENIC ARTERY. A RENEGADE STC 18 CATHETER WAS SELECTED FOR USE IN A SPLENIC ANEURYSM EMBOLIZATION. DURING PREPARATION, THE STC18 MICRO CATHETER WAS FLUSHED WITH SALINE. THE CATHETER WAS ADVANCED INTO THE PATIENT'S BODY THROUGH THE MICRO GUIDEWIRE. SUBSEQUENTLY, THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED AN INNER SHAFT DELAMINATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257502 ↗