Recall of Device Recall Zero tip

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, Basket, Ureteral, Metal - Product Code FFL
  • Reason
    The basket wire assembly may detach from the drive wire while in the patient.
  • Action
    U.S. and foreign consignees were notified via letter dated 12/20/05 and requested to return stocks on hand. Distributors were requested to notify their customers.


  • Model / Serial
    All units.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, Great Britain, Greece, Hong Kong, Ireland, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, South Korea, Singapore, South Africa, Spain and Sweden.
  • Product Description
    Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105.
  • Manufacturer


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