Events

Recall of Acrobat Stabilizer-Vacuum System

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
    2006-12-18
  • 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-de-systeme-stabilisateur-aspirateur-acrobat-de-la-societe-guidant-boston-scientific
  • 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
    The company Edwards Lifesciences has withdrawn from the market on December 15, 2006 the batches between 4120181 and 6100281 of the medical device called "Acrobat stabilizer-vacuum system" references OM9000S, OM9100S and XO49000S manufactured by GUIDANT-BOSTON Scientific Cardiac Surgery following a highlighting Vacuum leakage may result in partial loss of suction force during 2-year aging tests. As a result, the expiration is changed from 2 years to one year .. This device is used in cardiac surgery. The company has directly notified the recipients of the incriminated lots with the message attached (18/12/2006) (35 ko) validated by the Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. The competent European authorities concerned are informed of this measure by the manufacturer.

Device

Acrobat Stabilizer-Vacuum System

Manufacturer

Edwards Lifesciences