Events

Recall of Device Recall Stryker brand 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 Stryker Neurovascular.

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
    65654
  • Event Risk Class
    Class 2
  • Event Number
    Z-1808-2013
  • Event Initiated Date
    2013-06-24
  • Event Date Posted
    2013-07-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119819
  • 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
    The device is labeled incorrectly, in that, the device model number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. the model number on the outer box states upn m003e345020 (4.5mm x 20 mm neuroform 3 stent) while the pouch label states upn m003e3450300 (4.5mm x 30 mm neuroform 3 stent).
  • Action
    Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.

Device

Device Recall Stryker brand Neuroform 3 Microdelivery Stent System
  • Model / Serial
    Code: M003450200, Lot 15391019, Expiration Date: 2015-07
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    Yes
  • Distribution
    International Distribution including Austria, China, and Germany.
  • Product Description
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Manufacturer Address
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA