Recall of Device Recall LeVeen

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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
  • Action
    Distributors and user accounts were notified via medical device correction letter dated 7/29/05.


  • Model / Serial
    Lots 31804, 92702, 6538336, 6538341, 6556258, 6556462, 6556464, 6556634, 6826039, 7002067, 7021736, 7091482, 7108067, 7257089, 7356251, 7422492, 7457364, 7664972, 7667650, 21403R, 21703R and 92702R.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
  • Product Description
    Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
  • Manufacturer


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