Events

Recall of Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.

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
    Recall
  • Event ID
    33089
  • Event Risk Class
    Class 2
  • Event Number
    Z-1542-05
  • Event Initiated Date
    2005-07-29
  • Event Date Posted
    2005-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41305
  • 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.

Device

Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
  • Model / Serial
    Lots 7417267, 7481332 and 7606569.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Brazil, Canada, Hong Kong, Netherlands, Panama, Singapore and Taiwan.
  • Product Description
    Boston Scientific brand LeVeen Needle Electrode, 5.0/13/25; Model number M001262170,Ref 26-217.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

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