Events

Recall of Device Recall Cronus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stereotaxis 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
    28254
  • Event Risk Class
    Class 2
  • Event Number
    Z-0591-04
  • Event Initiated Date
    2004-01-27
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31774
  • 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
    unknown device name - Product Code NFN
  • Reason
    The magnet at the end of the guidewire could break off.
  • Action
    Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.

Device

Device Recall Cronus
  • Model / Serial
    Lots 0307-4029, 0307-4039, 0307-4042, 0307-4043, and 0307-4044
  • Product Classification
    Cardiovascular Devices
  • Distribution
    The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
  • Product Description
    Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3
  • Manufacturer
    Stereotaxis Inc

Manufacturer

Stereotaxis Inc
  • Manufacturer Address
    Stereotaxis Inc, 4041 Forest Park Ave, Saint Louis MO 63108-3213
  • Source
    USFDA