Events

Recall of Device Recall Cordis EMPIRA RX PTCA Dilatation 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
    64273
  • Event Risk Class
    Class 2
  • Event Number
    Z-1784-2014
  • Event Initiated Date
    2013-02-05
  • Event Date Posted
    2014-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115742
  • 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
    cardiovascular dilitation catheter - Product Code LOX
  • Reason
    Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.
  • Action
    An Urgent Medical Device Recall letter and Acknowledgement form was sent overnight to mulitple contacts in each account February 7, 2013. A representative will follow-up as necassary to facility obtaining signature, faxing the acknowledgment form to Cordis, collecting and returning units.

Device

Device Recall Cordis EMPIRA RX PTCA Dilatation Catheter
  • Model / Serial
    Catalog # 85R30300S LOT # CE0001447 exp date: 2014-08
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US states: AZ, FL, IL, LA, MA, NJ, OR, SC, and TX. Armenia, Austria, Belgium, Colombia, Czech Republic, France, Hungary, Iran, Israel, India, Italy, Kuwait, Latvia, Lebanon, Luxembourg, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Switzerland, and United Arab Emirates.
  • Product Description
    Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
  • 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