Events

Recall of REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER

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
    97170
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-08
  • 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
    The manufacturer has received reports of the tubing strain relief component of the realize injection port becoming displaced from the locking connector and in some cases migrating from its original position on the locking connector. displacement of the strain relief component may result in kinking of the catheter which may prevent adjustment of fluid volume potentially rendering the product ineffective and requiring additional surgery to correct. in addition the strain relief component may migrate and become a foreign body within the abdomen which may require surgery to remove. implanted devices do not need to be removed because of this recall.

Device

REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER

Manufacturer

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