Direxion™ HI-FLO™ M001195510Recalls & reported problems
Boston Scientific Corporation · Torqueable Microcatheter · Class 2
All models of Direxion HI-FLO (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729839583), received between May 11, 2020 and May 11, 2020 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2020Break; Break
IT WAS REPORTED THAT A CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS RIGHT BUTTOCKS ARTERY. A DIREXION HI-FLO WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN ABOUT 50 CM IN OR ABOUT HALF WAY INTO THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED, BUT THE SYSTEM WAS LOST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND NO NEGATIVE SEQUEALAE TO THE PATIENT CONDITION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10043091 ↗
Other Catheter, continuous flush devices
- PROWLER SELECT 606-S255XMedos International Sàrl · Catheter, continuous flush2 deaths980 reports
- PhenomTM 27 Catheter FG15150-0615-1SMicro Therapeutics, Inc. · Catheter, continuous flush2 deaths139 reports
- MarathonTM 105-5056Micro Therapeutics, Inc. · Catheter, continuous flush124 reports
- 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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