Events

Recall of CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    54093
  • Event Risk Class
    III
  • Event Initiated Date
    2011-03-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    There is a typographical error on one of the 4 peel-off stickers that are placed on the subject product packaging. the information on one of the stickers on the sterile pouch inside of the product box indicates the stent size to be 22mm in length when in fact the product is 28mm in length.

Device

CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
  • Model / Serial
    Model Catalog: ENF452812 (Lot serial: 1421338); Model Catalog: ENF452812 (Lot serial: 1421601); Model Catalog: ENF452812 (Lot serial: 2420432); Model Catalog: ENF452812 (Lot serial: 1422396)
  • Product Description
    CODMAN ENTERPRISE VASCULAR RECONSTRUCT.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.