Events

Recall of Zenith Flex AAA

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

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
    58613
  • Event Risk Class
    Class 3
  • Event Number
    Z-3146-2011
  • Event Initiated Date
    2011-04-15
  • Event Date Posted
    2011-09-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99824
  • 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
    endovascular graft system - Product Code MIH
  • Reason
    The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.
  • Action
    The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.

Device

Zenith Flex AAA
  • Model / Serial
    F2629606, F2629608
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US, Canada, Japan
  • Product Description
    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA