Events

Recall of Cordis ADROIT 6F Guiding Catheter

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
    66026
  • Event Risk Class
    Class 2
  • Event Number
    Z-0003-2014
  • Event Initiated Date
    2013-08-12
  • Event Date Posted
    2013-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121288
  • 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
    Catheter, percutaneous - Product Code DQY
  • Reason
    Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. the english dimension is correct and is the primary dimension.
  • Action
    Cordis sent an Urgent Medical Device Recall letter dated August 12, 2013 Acknowledgement Form to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to immediately identify and set aside all affected product in a manner that ensures the product will not be used. Customers were asked to review, complete, sign and return the enclosed Acknowledgement form directly to Cordis to the fax number on the form. For questions call the Customer Service number at 800-561-7683.

Device

Cordis ADROIT 6F Guiding Catheter
  • Model / Serial
    Catalog Lots  ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of AZ, CA, FL, ID, LA, MA, MD, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TX, VA, WI, and WV and the countries of: Austria, Belgium, Czech Republic, France, Germany, Greece,Hungary, Israel, Italy, Latvia, Netherlands, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, United Arab, and United Kingdom
  • Product Description
    Cordis ADROIT 6F Guiding Catheter || Product Usage: || For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
  • Manufacturer
    Cordis Corporation

Manufacturer

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