Renegade STC 18Recalls & reported problems across all models
Boston Scientific Corporation · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of Renegade STC 18 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Feb 24, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Break” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Renegade STC 18 problems
Device problems
- Break8
- Difficult to Advance5
- Material Integrity Problem4
- Detachment of Device or Device Component3
- Failure to Advance3
- Contamination2
- Defective Device2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient9
- No Patient Involvement4
- Obstruction/Occlusion1
Renegade STC 18 models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Renegade™ STC 18 M001181310CATHETER, INTRAVASCULAR, DIAGNOSTIC13 reports
- Renegade™ STC 18 M001181370CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- Renegade™ STC 18 M001181270CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Renegade™ STC 18 M001181330CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- Renegade™ STC 18 M001181380CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- Renegade™ STC 18 M001181250CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- Renegade™ STC 18 M001181340CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent Renegade STC 18 adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗MalfunctionFeb 7, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT CATHETER WAS PUNCTURED. A RENEGADE STC 18 WAS SELECTED FOR USE IN A SEVERELY CALCIFIED VESSEL. DURING THE PROCEDURE, UPON INSERTION OF THE GUIDEWIRE, IT WAS NOTED THAT THE CATHETER WAS PUNCTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FINE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18664167 ↗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 ↗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 ↗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 ↗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 ↗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 ↗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 ↗MalfunctionApr 29, 2021Collapse; Obstruction of Flow; Collapse; Obstruction of Flow
BASED ON DEVICE ANALYSIS COMPLETED ON 05APR2021. IT WAS REPORTED THAT DISTAL PART OF THE CATHETER WAS BULGING. A 150/30 RENEGADE STC 18 WAS SELECTED FOR USE. UPON PREPARATION, IT WAS NOTED THAT THE DISTAL PART OF THE MICROCATHETER WAS OBSTRUCTED. SUBSEQUENTLY, THERE WAS A BULGING IN THE DISTAL PART APPROXIMATELY 3-4CM. NO PATENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED AN OBSTRUCTION OF FOREIGN MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11744885 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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