Direxion™ HI-FLO™ Fathom™-16 System M001195960Recalls & reported problems
Boston Scientific Corporation · Pre-Loaded Torqueable Microcatheter · Class 2
All models of Direxion HI-FLO Fathom-16 System (4)
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 08714729991069), received between Aug 23, 2021 and Aug 23, 2021 — 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 Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2021Break
PATIENT WITH RECENT HISTORY OF ABDOMINAL PAIN, HEMATEMESIS, CARDIAC ARREST FOLLOWED BY RESUSCITATION WAS ADMITTED FOR AN INTERVENTIONAL RADIOLOGY EMBOLIZATION. THE PRE-LOADED TORQUEABLE MICROCATHETER FROM THE DIREXION¿ HI-FLO¿ FATHOM¿-16 SYSTEM BROKE OFF DURING THE PROCEDURE. EVERYTHING WAS REMOVED WITHOUT KNOWN HARM TO THE PATIENT. THE FAULTY DEVICE WAS EXCHANGED TO CONTINUE WITH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12352763 ↗
Other Catheter, continuous flush devices
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- 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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