Renegade™ HI-FLO™ M001182840Recalls & reported problems
Boston Scientific Corporation · Microcatheter · Class 2
All models of Renegade HI-FLO (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08714729280590), received between Aug 9, 2022 and Aug 9, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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
Device problems
- Difficult to Open or Remove Packaging Material2
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.
MalfunctionAug 9, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19JUL2022. IT WAS REPORTED THAT THE MICROCATHETER WOULD NOT RELEASE FROM THE HOOP. A 105/10 RENEGADE HI-FLO MICROCATHETER WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE MICROCATHETER WOULD NOT RELEASE FROM THE HOOP. AFTER FLUSHING THE INSIDE AND THE OUTSIDE OF THE MICROCATHETER, IT WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MICROCATHETER FRACTURE LOCATED AT 22.7CM FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15193535 ↗MalfunctionAug 9, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE MICROCATHETER WOULD NOT RELEASE FROM THE HOOP. A 105/10 RENEGADE HI-FLO MICROCATHETER WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE MICROCATHETER WOULD NOT RELEASE FROM THE HOOP. AFTER FLUSHING THE INSIDE AND THE OUTSIDE OF THE MICROCATHETER, IT WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MICROCATHETER FRACTURE LOCATED AT 44.1CM FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192775 ↗
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- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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