Events

Recall of Guidant Multi-Link Vision 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
    25945
  • Event Risk Class
    Class 2
  • Event Number
    Z-0775-03
  • Event Initiated Date
    2003-04-01
  • Event Date Posted
    2003-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26752
  • 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
    Complaints that the stents are being dislodged from the delivery system.
  • Action
    Information as an Advisory Notice was sent by facsimile to the Competent Authorities and to distributors on April 1 2003. Recall letters will be delivered by hand in most instances.

Device

Guidant Multi-Link Vision Coronary Stent System
  • Model / Serial
    All lots are included in the action.
  • Product Classification
    Cardiovascular Devices
  • Distribution
    No USA distribution, only to the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Lebanon, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Tunisia, United Kingdom.
  • Product Description
    Guidant Multi-Link Vision Coronary Stent System || Catalog Numbers: 30 different catalog numbers have been listed. || The firm indicates that total numbers of devices subject to this removal are being defined.
  • Manufacturer
    Guidant Corporation ACS

Manufacturer

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