Renegade™ STC 18 M001181380Recalls & reported problems
Boston Scientific Corporation · Microcatheter · Class 2
All models of Renegade STC 18 (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729444510), received between Oct 3, 2019 and Apr 29, 2021 — classified as 2 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
Device problems
- Break1
- Collapse1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionOct 3, 2019Break; Break
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN RIGHT ILIAC ARTERY. A 150/30 RENEGADE STC-18 WAS SELECTED FOR USE IN ABDOMINAL AORTIC ANEURYSM. DURING UNPACKING, IT WAS NOTED THAT THE CATHETER WAS FRACTURED. THE CATHETER SURFACE WAS FLUSHED AND THE CARRIER TUBE WAS HYDRATED A FEW SECONDS PRIOR TO REMOVING THE DEVICE FROM THE CARRIER TUBE. THERE WAS NO RESISTANCE FELT DURING REMOVAL OF THE CATHETER FROM THE CARRIER TUBE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9152010 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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