Recall of Device Recall LeVeen Needle Electrode

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    tissue coagulation - Product Code GEI
  • Reason
    The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.
  • Action
    Boston Scientific notified consignees by letter dated 7/6/09 and instructed to cease using and to return the products, and to complete and return a reply form.


  • Model / Serial
    Lots 8839481, 8900349, 9043740, 9084603, 9296400, 9300554, 9442864, 9531903, 9569178, 9707800, 9746026, 9787308, 11182329, 11203869, 11350192, 11403787, 11518357, 11559944, 12219051 and 12475134.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Boston Scientific, LeVeen Needle Electrode, 25 cm, 5.0 cm, sterile; REF M001262170. For tissue coagulation.
  • Manufacturer


  • Manufacturer Address
    Boston Scientific Corp, 780 Brookside Dr, Spencer IN 47460-1080
  • Source