Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Edwards Lifesciences.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 018 01 11 000
  • Event Initiated Date
    2011-01-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=33
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    Edwards lifesciences is announcing a field safety notice (fsn) on all loader assemblies contained within the ascendra 2 delivery systems (the ascendra 2 delivery system consists of a balloon catheter and a loader, model number 9320as23 or 9320as26). edwards has received reports where, during the transapical procedure, the loader assembly de-airing mechanism has become partially unseated thereby creating an insufficient seal around the pusher and resulting in the leakage of blood.

Device

Ascendra 2 Delivery System
  • Model / Serial
    Model Number: 9320AS23 and 9320AS26. all lot numbers
  • Product Description
    Catheter, cardiac, valvuloplasty
  • Manufacturer
    Edwards Lifesciences

Manufacturer

Edwards Lifesciences