Events

Recall of CARTO 3 EP NAVIGATION 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
    152581
  • Event Risk Class
    II
  • Event Initiated Date
    2009-11-26
  • 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
    Biosense webster inc. has recently become aware of a potential hazard that may occur during the operation of the bloom dtu-215b cardiac stimulator (not a j & j device) in conjunction with rf generators and ep equipment including the carto 3 system. if rf energy and pacing stimuli are delivered simultaneously across the same electrode pair a dc voltage may be generated. this can cause micro-bubbles in the blood within the heart chamber.

Device

CARTO 3 EP NAVIGATION SYSTEM
  • Model / Serial
    Model Catalog: FG540000 (Lot serial: 2246); Model Catalog: FG540000 (Lot serial: 3257); Model Catalog: FG540000 (Lot serial: 4166); Model Catalog: FG540000 (Lot serial: 4184); Model Catalog: FG540000 (Lot serial: 4203)
  • Product Description
    CARTO 3 EP MAPPING SYSTEM
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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