Events

Recall of Device Recall Fire Star

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

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
    46378
  • Event Risk Class
    Class 1
  • Event Number
    Z-0822-2008
  • Event Initiated Date
    2008-01-14
  • Event Date Posted
    2008-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67909
  • 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
    Dilatation Catheter - Product Code LOX
  • Reason
    Slow deflation or no deflation.
  • Action
    Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.

Device

Device Recall Fire Star
  • Model / Serial
    Lot #s: 13206014 13214558 13218325 13223381 13239284 13281261 13281440 13281442 13294224 13294227 13294232 13303772 13308632 and 13312726
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    CORDIS "Fire Star" 3.00 x 30 Dilatation Catheter, Catalog # 80130300, Distributed by Cordis Corporation, Miami Lakes, FL 33014
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Manufacturer Address
    Cordis Corporation, 14201 NW 60th Avenue, Miami Lakes FL 33014-2802
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA