Renegade™ - 18 M001182570Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729301110), received between Jul 30, 2018 and Aug 29, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 29, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE GUIDEWIRE WAS ADVANCED IN THE MICROCATHETER (SUBJECT DEVICE), THE GUIDEWIRE PERFORATED BETWEEN THE TWO TIPS OF THE MICROCATHETER, CAUSING A HOLE. THE PHYSICIAN REPLACED IT WITH A NEW MICROCATHETER AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8948187 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT THE DEVICE CAN'T BE REMOVED FROM THE HOOP DESPITE FLUSHING SEVERAL TIMES, FINALLY THE DEVICE WAS STRETCHED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8075987 ↗
• MalfunctionJul 30, 2018Break; Break

  REVIEW OF THE INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE CATHETER SHAFT WAS FRACTURED. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733859 ↗