Events

Recall of Device Recall Wingspan Stent System

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
    56716
  • Event Risk Class
    Class 2
  • Event Number
    Z-0627-2011
  • Event Initiated Date
    2010-08-25
  • Event Date Posted
    2010-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94345
  • 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
    Intracranial Neurovascular Stent - Product Code NJE
  • Reason
    Products may not meet radial force specifications.
  • Action
    Recall initiated August 25, 2010. "Urgent Medical Device Recall - Immediate Action Required" notifications, dated 25 August 2010, were delivered by FedEx where possible, and by personal delivery assigned to sales representatives. The letter identified the affected product and the reason for recall. The letter stated that further distribution or use of any remaining product should cease immediately. Customers were asked to read the enclosed instructions and told that their local Sales Rep could answer any questions that they may have regarding the recall.

Device

Device Recall Wingspan Stent System
  • Model / Serial
    Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
  • Product Description
    Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA || Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA