Events

Recall of Device Recall Zilver 518 Vascular Self Expanding Stent

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

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
    61451
  • Event Risk Class
    Class 2
  • Event Number
    Z-2309-2012
  • Event Initiated Date
    2012-01-05
  • Event Date Posted
    2012-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108136
  • 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
    Cook ireland received a product complaint from japan on december 22nd, 2011. the complainant reported that a 5 french zilver vascular stent (part number ziv5-18-125-8-80 from lot# cf694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. after further examination, the user determined that the product was a 6 french zilver vascular stent (part number ziv6-35.
  • Action
    The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: rita.harden@cookmedical.com; OUS: Customer Quality Supervisor at +353 61 239343.

Device

Device Recall Zilver 518 Vascular Self Expanding Stent
  • Model / Serial
    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Japan.
  • Product Description
    Zilver 518 Vascular Self Expanding Stent || The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
  • Manufacturer
    Cook Ireland Ltd.

Manufacturer

Cook Ireland Ltd.
  • Manufacturer Address
    Cook Ireland Ltd., O'holloran Road,, National Technological Park, Limerick, Peroc Ireland
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA