Events

Recall of Device Recall Zilver 518RX Vascular Stent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Medical Incorporated.

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
    72965
  • Event Risk Class
    Class 2
  • Event Number
    Z-0689-2016
  • Event Initiated Date
    2015-12-22
  • Event Date Posted
    2016-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142598
  • 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
    Stent, iliac - Product Code NIO
  • Reason
    Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. failure of this joint during a procedure may result in a partial stent deployment. the clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event.
  • Action
    Cook Medical sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 22, 2015, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235. On 2/5/2016 a second recall notification was sent to affected consignees, expanding the recall to All Lots of the affected product.

Device

Device Recall Zilver 518RX Vascular Stent
  • Model / Serial
    Catalog Prefix ZIVX5. All Lots
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Worldwide
  • Product Description
    Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
  • Manufacturer
    Cook Medical Incorporated

Manufacturer

Cook Medical Incorporated
  • Manufacturer Address
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA