Direxion™ Fathom™-16 System M001195660Recalls & reported problems
Boston Scientific Corporation · Pre-Loaded Torqueable Microcatheter · Class 2
All models of Direxion Fathom-16 System (6)
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 08714729839651), received between Apr 19, 2023 and Apr 19, 2023 — 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.
MalfunctionApr 19, 2023Break; Break
IT WAS REPORTED THAT THE MICROCATHETER WAS BROKEN. THIS DIREXION FATHOM-16 SYSTEM MICROCATHETER WAS SELECTED FOR USE, AND DURING THE PROCEDURE THE CONTRAST WAS OBSERVED FROM WHERE THE MICROCATHETER WAS BROKEN. THE MICROCATHETER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW DIREXION MICROCATHETER. NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773902 ↗
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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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