Renegade™ STC 18 M001181270Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729444404), received between Oct 17, 2018 and Feb 7, 2024 — 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.

• 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 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER WAS FRACTURED. A RENEGADE STC-18 MICROCATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, INTRODUCING THE MICROCATHETER WAS SMOOTH. HOWEVER, WHEN THE CHEMO-DRUG WAS INJECTED, THE PHYSICIAN FOUND THAT THE FLOW OF THE DRUG WAS ABNORMAL AND DID NOT GO TOWARD THE TARGET VESSEL UNDER ANGIOGRAM. SO, HE REMOVED THE MICROCATHETER WITHOUT FRICTION AND TESTED IT OUTSIDE OF THE PATIENT'S BODY. THEN, HE FOUND A FRACTURE IN THE DISTAL OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514737 ↗
• MalfunctionOct 17, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS TORN. A 105/20 RENEGADE STC 18 WAS SELECTED FOR USE. DURING UNPACKING, IT WAS OBSERVED THAT THERE WAS SOME KIND OF A TEAR IN THE CATHETER. DEVICE WAS NEVER USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7973673 ↗