Renegade™ M001182530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729322832), received between Aug 31, 2018 and Jan 23, 2024 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 50/20/1TIP RENEGADE MICROCATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE STERILE TECH OPENED THE PACKAGE AND WENT TO TAKE THE CATHETER, A HAIR WAS SEEN INSIDE THE PACKAGE. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565524 ↗
• MalfunctionOct 5, 2020Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. A RENEGADE CATHETER WAS SELECTED FOR USE. DURING REMOVAL FROM THE PACKAGING, THE CATHETER SURFACE WAS HYDRATED LESS THAN 30 SECONDS PRIOR TO REMOVAL FROM THE CARRIER HOOP. RESISTANCE WAS FELT DURING FIRST TRIAL OF REMOVAL AND IT WAS NOTED THAT THE CATHETER BECAME SEPARATED. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627522 ↗
• MalfunctionAug 22, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. A 150/20/1TIP RENEGADE WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING UNPACKING, THE DISTAL PART OF THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8921933 ↗
• MalfunctionAug 31, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SHAFT. A 150/20/1 RENEGADE WAS SELECTED FOR USE. DURING PREPARATION, A HOLE WAS NOTED IN THE OUTER SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837897 ↗