Events

Recall of Guidant Multi-Link Zeta Coronary Stent System

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

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
    26836
  • Event Risk Class
    Class 2
  • Event Number
    Z-1075-03
  • Event Initiated Date
    2003-07-15
  • Event Date Posted
    2003-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28536
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Potential loss of package sterility.
  • Action
    Firm personnel in China have inspected all Chinese consignee end user inventories. Any units found to be defective have been removed and are currently in Guidant control.

Device

Guidant Multi-Link Zeta Coronary Stent System
  • Model / Serial
    3050632 3060432 3060251 3051952 3052251 3060331 3051231 3051951 3052752 3052031 3051931 3050651 3052752 3060531 3060451 3050751 3052251 3051951 3050931 3050632 3052032 3060251 3051531 3053051 3051634 3051632 3053051 3051531 3052952 3051552 3050931 3052852 3060431 3060432 3050751 3052131 3051532 3052031 3051631 3050251 3043051 3050931 3051531 3051451 3052851 3051551 3051531 3041031
  • Product Classification
    Cardiovascular Devices
  • Distribution
    China
  • Product Description
    Guidant Multi-Link Zeta Coronary Stent System
  • Manufacturer
    Guidant Corporation ACS

Manufacturer

Guidant Corporation ACS
  • Manufacturer Address
    Guidant Corporation ACS, 26531 Ynez Road, Temecula CA 92591-4628
  • Source
    USFDA