Recall of Device Recall Stonetome

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
    Dislodger, Stone, Biliary - Product Code LQR
  • Reason
    Lack of assurance of sterility, as the sterile barrier may fail.
  • Action
    Consignees were notified to cease using, and to return, the products via recall letter dated May 19, 2006. International customers were also notified.


  • Model / Serial
    All lots. Lots 6546667, 6602514, 6706832, 6763251, 6811777, 6848204, 6930829, 7022531, 7078442, 7172641, 7283354, 7375263, 7467937, 7620507, 7725395, 7752678, 8037806, 8133510, 8230614, 8331439, 8360757, 8360758, 8384930, 8384931, 8411892, 8411893, 8411894, 8411895 and 8534126.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide, Arab Emirate, Australia, Austria, Belgium, Canada, Denmark, Finland, France, germany, Great Britain, Hong Kong, Israel, Italy, Japan, Libya, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey, Taiwan, Venezuela and Viet Nam.
  • Product Description
    Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
  • Manufacturer


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