Renegade™ STC 18 M001181310Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729444442), received between Sep 26, 2018 and Feb 24, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A RENEGADE? STC 18 CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP WAS RUPTURED. THE PROCEDURE WAS COMPLETED USING WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434576 ↗
• MalfunctionDec 18, 2024Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN A VESSEL OF BELOW THE KNEE. A RENEGADE STC 18 WAS SELECTED FOR USE IN THE EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS ADVANCE INSIDE THE CATHETER, HOWEVER, RESISTANCE WAS NOTED, AND THE COIL COULD NOT BE DEPLOYED. CONSEQUENTLY, THE ACCESS WAS LOST. THE COIL AND THE MICROCATHETER WERE REMOVED. THE MICROCATHETER WAS FLUSHED, AND IT WAS NOTED THAT THERE IS A LEAKAGE IN THE CATHETER. MULTIPLE APPROACHES WERE TRIED BUT FAILED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20966156 ↗
• MalfunctionJun 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT MARKERBAND MALPOSITION OCCURRED. A RENEGADE STC 18 WAS SELECTED FOR USE IN A GASTRIC ARTERIAL HEMORRHAGE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MARK POINT OF THE MICROCATHETER IMAGING WAS LOCATED NEARLY 1 CM AWAY FROM THE TIP OF THE MICROCATHETER. THUS, THE COIL COULD NOT BE RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556844 ↗
• MalfunctionDec 20, 2022Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GUIDE WIRE WAS WITHDRAWN WITH FOREIGN BODY. A 130/20/STRAIGHT/1RO RENEGADE STC-18 MICROCATHETER WAS USED IN A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS RESISTANCE UPON DELIVERING THE GUIDE WIRE, HOWEVER THE GUIDE WIRE WAS WITHDRAWN WITH FOREIGN BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE FOUND FOREIGN BODY WAS LIKE A COTTON WOOL. ALSO, THE GUIDEWIRE DIDN'T HAVE PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018302 ↗
• MalfunctionAug 19, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE TIP WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 130/20 RENEGADE STC-18 CATHETER INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS HYDRATED USING INTERMITTENT FLUSHING. UPON ADVANCING, THE COIL CANNOT BE INSERTED, AND IT WAS NOTED THAT THE TIP WAS BROKEN AND CRUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262739 ↗
• MalfunctionJun 3, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING OF RENEGADE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LIVER. A RENEGADE STC 18 CATHETER-INFUSION WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COATING OF RENEGADE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14592571 ↗
• MalfunctionNov 22, 2021Difficult to Remove; Difficult to Advance; Difficult to Open or Remove Packaging Material; Material Integrity Problem; Difficult to Remove; Difficult to Advance; Difficult to Open or Remove Packaging Material; Material Integrity Problem

  IT WAS REPORTED COATING DAMAGE OCCURRED. AN STC 18 130CM X 20CM RENEGADE WAS SELECTED FOR USE IN AN UNKNOWN PROCEDURE. DURING REMOVING THE RENEGADE CATHETER FROM THE CARRIER HOOP, AFTER FLUSHING, INSERTING A FATHOM GUIDEWIRE, AND CONNECTING A TORQUE DEVICE, RESISTANCE WAS FELT. THE PHYSICIAN THEN ADVANCED THE RENEGADE INTO A 5F 0.038 NON-BSC GUIDE CATHETER WHEN STRONG RESISTANCE OCCURRED AFTER SOME CENTIMETERS. ALTHOUGH THE FATHOM WAS ADVANCED INTO THE GASTRODUODENAL ARTERY (GDA) WELL, THE RENEGADE COULD NOT FOLLOW BECAUSE OF THE RESISTANCE. THE RENEGADE WAS REMOVED WITH SOME RESISTANCE AS WELL, AND A SMALL PART OF THE OUTER COATING WAS NOTICED TO BE DISRUPTED OVER 2 CM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851141 ↗
• MalfunctionMay 11, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SHAFT WAS BROKEN. A RENEGADE STC 18 CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHEN TAKING OUT THE DEVICE FROM THE CARRIER, THERE WAS TOO MUCH FRICTION FELT BETWEEN THE CATHETER AND CARRIER. THE DEVICE WAS SUCCESSFULLY TAKEN OUT, HOWEVER THE PROXIMAL SHAFT WAS BROKEN. THE DEVICE HAD NOT BEEN ADVANCED TO THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807240 ↗
• MalfunctionNov 16, 2020Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE MICROCATHETER WAS FRACTURED. A RENEGADE STC 18 CATHETER INFUSION WAS SELECTED FOR USE IN TRANSARTERIAL CHEMOEMBOLIZATION (TACE). DURING PREPARATION, THE OUTER PACKAGE WAS UNPACKED. HOWEVER, IT WAS DISCOVERED THAT THE TIP OF THE MICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848156 ↗
• MalfunctionDec 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A 130/20 RENEGADE STC 18 INFUSION CATHETER SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THEMICROCATHETER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458617 ↗
• MalfunctionApr 15, 2019Contamination; Contamination

  IT WAS NOTED THAT THE STERILE PACKAGING OF THE PRODUCT WAS CONTAMINATED WITH HAIR. A 130/20 RENEGADE STC 18 WAS SELECTED FOR USE FOR THE PROCEDURE. PRIOR TO THE PROCEDURE, UPON OPENING THE STERILE PACK OF THE REPORTED PRODUCT, A HAIR WAS FOUND INSIDE THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 8515828 ↗
• MalfunctionApr 15, 2019Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT THE FATHOM WIRE WOULD PASS THROUGH THE CATHETER. A 130/20 RENEGADE STC 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FATHOM WIRE WOULD NOT PASS THOROUGH TAPERED TIP OF THE RENEGADE CATHETER. SUBSEQUENTLY, THE DEVICE WAS REMOVED THROUGH THE INTRODUCER SHEATH AND NO DAMAGE WAS NOTED ON THE FATHOM WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. HOWEVER, DEVICE ANALYSIS REVEALED DELAMINATION OF THE OUTER SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514787 ↗
• MalfunctionSep 26, 2018Contamination; Contamination

  IT WAS REPORTED THAT INNER PACKAGE OF DEVICE WAS FOUND CONTAMINATED. A RENEGADE STC 18 WAS USED FOR EMBOLIZATION. DURING UNPACKING, IT WAS FOUND OUT THAT THE INNER PACKAGE OF THE DEVICE WAS CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7910686 ↗