Events

Recall of Swann Ganz continuous flow catheters (CCO)

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
    2010-05-14
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-catheters-de-swan-ganz-a-debit-continu-cco-par-edwards-lifesciences2
  • 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    On 10/05/2010, the company Edwards Lifesciences has withdrawn from the market batches of the medical device called "Swann Ganz continuous flow catheters (CCO)", reference 744HF75 lot 58615355 and reference 746HF8 lot 58612699 as a result of an electronic problem at the connector of the thermal filament of the catheter. This defect causes impossible measurements of cardiac output and the display of an error message on the alertness monitor. This recall, similar to that carried out in February 200, is implemented following the highlighting by the industrialist of new lots concerned .. The company Edwards Lifesciences directly warned the recipients of the incriminated lots with the help of the message attached (14/05/2010) (24 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Swann Ganz continuous flow catheters (CCO)

Manufacturer

Edwards Lifesciences