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Direxion™ M001195350Recalls & 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 08714729839460), received between Sep 13, 2022 and Sep 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • MalfunctionSep 13, 2022Material Deformation; Material Deformation

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE MICRO CATHETER GOT KINKED. THE TARGET LESION WAS LOCATED IN THE LIVER. A 155MM DIREXION CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICRO CATHETER GOT KINKED UPON SUPER SELECTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS FRACTURED 25.5CM FROM THE HUB.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15414931 ↗

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Sources and updates

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