Events

Recall of Device Recall Boston Scientific

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

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
    37068
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-2007
  • Event Initiated Date
    2006-12-20
  • Event Date Posted
    2007-03-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49846
  • 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
    Wallstent Endoscopic Biliary Endoprosthesis - Product Code FGE
  • Reason
    Guidewire restriction during use (excessive adhesive in the guidewire lumen).
  • Action
    On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.

Device

Device Recall Boston Scientific
  • Model / Serial
    Lot Numbers: 7892444, 7909244, 7909250, 8326863, 8502339, 8541943, 8652467, 8771022, 8831247, 8956367, 8956369
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.
  • Product Description
    Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA