Events

Field Safety Notices about CARTOSOUND® Module in conjunction with SOUNDSTAR® eco 8F and eco10F Catheters

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Biosense Webster, a division of Johnson & Johnson Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-09-21
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The intra-cardiac ultrasound image will disappear if the carto® 3 ep navigation system power is disrupted and this may present a safety issue if the electrophysiologist is using the ultrasound imaging to monitor the patient during the electrophysiology procedure. the ultrasound image will not reappear until the carto® 3 system is restored.

Device

CARTOSOUND® Module in conjunction with SOUNDSTAR® eco 8F and eco10F Catheters

Manufacturer

Biosense Webster, a division of Johnson & Johnson Medical