Events

Recall of Device Recall Neuroform 3 Microdelivery 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
    52668
  • Event Risk Class
    Class 2
  • Event Number
    Z-2052-2009
  • Event Initiated Date
    2009-05-08
  • Event Date Posted
    2009-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83602
  • 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
    Mislabeling-- product was placed in a carton, which has printed on it the name of another product. a correct product label was placed on the carton.
  • Action
    The firm issued an Urgent Product Field Action Notice to all listed customers, along with a reply verification form, requesting the return of affected products.

Device

Device Recall Neuroform 3 Microdelivery Stent System
  • Model / Serial
    Batch numbers 8048028 and 8048029.
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    International Distribution Only -- Countries of Germany, Great Britain, France, Ireland, and Italy.
  • Product Description
    Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA.
  • 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