Neuro Renegade® Hi-Flo™ M003182900US0Recalls & reported problems
Boston Scientific Corporation · Microcatheter · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729767510), received between Sep 30, 2016 and Jul 27, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
Device problems
- Break3
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2017Break; Break
BASED ON THE INVESTIGATION OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE CATHETER SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6748074 ↗MalfunctionSep 30, 2016Break; Break
THE MICROCATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE OUTER SHAFT OF THE MICROCATHETER HAD SEPARATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 5991947 ↗MalfunctionSep 30, 2016Break; Break
THE MICROCATHETER WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE CATHETER DISTAL TIP WAS RIPPED OFF. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5991945 ↗
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- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.