Direxion™ M001195310Recalls & reported problems
Boston Scientific Corporation · Torqueable Microcatheter · Class 2
All models of Direxion (14)
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 08714729839422), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Rupture1
- Obstruction of Flow1
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.
MalfunctionJul 11, 2022Difficult to Remove; Material Rupture; Obstruction of Flow; Difficult to Remove; Material Rupture; Obstruction of Flow
IT WAS REPORTED THAT MICROCATHETER BECAME OCCLUDED AND THE OUTER LAYER RUPTURED UNDER PRESSURE. THIS DIREXION MICROCATHETER WAS SELECTED FOR USE FOR A PELVIC EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT THE CATHETER BECAME BLOCKED AND THE OUTER LAYER RUPTURED UNDER PRESSURE. THE RUPTURE MADE THE CATHETER DIFFICULT TO REMOVE, HOWEVER THEY WERE ABLE TO REMOVE THE ENTIRE MICROCATHETER AND PROBE ASSEMBLY WITHOUT SEQUELA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14978219 ↗
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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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