Renegade™ HI-FLO™ Kit M001183010Recalls & reported problems
Boston Scientific Corporation · Microcatheter Kit · Class 2
- 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 08714729280767), received between Aug 21, 2025 and Jan 14, 2026 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Obstruction of Flow; Material Integrity Problem
IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROSTATE ARTERY. A 115/20 KIT RENEGADE HI FLO CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE WIRE IN THE CATHETER HAD BEEN NAVIGATED TO THE INTENDED LOCATION. HOWEVER, THE COATING FROM THE WIRE CAUSED THE CATHETER TO BECOME CLOGGED, PREVENTING ANYTHING FROM PASSING THROUGH. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED 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 24075015 ↗MalfunctionAug 21, 2025Break; Break
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 115/20 RENEGADE HI FLO WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INSERTION INTO THE PATIENT, IT WAS NOTED THAT THE MICROCATHETER SNAPPED NEAR THE HUB. THE FRACTURE OCCURRED AT A PORTION OF THE DEVICE OUTSIDE OF THE PATIENT'S BODY, AND THE DEVICE WAS REMOVED INTACT AND IN ONE PIECE WITHOUT REQUIRING ANY ADDITIONAL RETRIEVAL METHODS. BECAUSE THERE WAS NO BACKUP CATHETER AVAILABLE, THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859734 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.