Recall of Prowler Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cordis Neurovascular, 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    These catheters have j-shape tips instead of the labeled mp (multipurpose) tips and also are packed into the incorrect tip tray.
  • Action
    The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.


  • Model / Serial
    Catalog No. 606-2511 FX UPN H7396062511FX3 Lot T0601010, expiration date 2004-05
  • Product Classification
  • Distribution
    Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan.
  • Product Description
    Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
  • Manufacturer


  • Manufacturer Address
    Cordis Neurovascular, Inc., 14000 NW 57th Ct., Miami Lakes FL 33014
  • Source