Events

Recall of Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82.

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
    30721
  • Event Risk Class
    Class 2
  • Event Number
    Z-0502-05
  • Event Initiated Date
    2004-12-20
  • Event Date Posted
    2005-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36488
  • 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
    System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
  • Reason
    The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
  • Action
    Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.

Device

Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 30...
  • Model / Serial
    All units distributed on or before 12/17/04.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B; One-Shot Introduction System( A= 30mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-82.
  • Manufacturer
    Cook, Inc.

Manufacturer

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