Events

Recall of AVA 3Xi Venous Access Device

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Edwards Lifesciences.

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
  • Date
    2002-09-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dispositif-d-acces-veineux-ava-3xi-references-m3l85fhs-et-m3l85fhsi-de-la-societe-edwards-lifesciences
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    On September 6, 2002, Edwards Lifesciences removed from market 942CC186 942CC189 942CC190 and 942EC741 lots of M3L85FHS and M3L85FHSI references for the AVA 3Xi Venous Access Device following claims for leaks at the introducer valve. This device is used in patients requiring access to the venous system or to facilitate the insertion of a catheter (arterial pulmonary or infusion) and monitoring of central venous pressure.

Device

AVA 3Xi Venous Access Device

Manufacturer

Edwards Lifesciences