Events

Rappel de Extracorporeal Circulatory Circulation (ECC)

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par MEDTRONIC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2008-05-21
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-et-information-concernant-des-dispositifs-de-circulation-extra-corporelle-de-la-societe-medtronic
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Some of the Medtronic Extracorporeal Circulatory Circulation (ECC) devices were manufactured with heparin lots contaminated with persulfated chondroitin. Medtronic, in agreement with Afssaps and following the risk analysis it conducted on these products, decided to. recall CEC devices with Carmeda® surface treatment. The attached letter (21/05/2008) (31 KB) has been sent to the users concerned. make facilities available for Trillium® surface treatment CECs until uncontaminated alternatives are available. The enclosed information letter (21/05/2008) (34 KB) has been distributed to users. This action was considered acceptable to the extent that no adverse effects have been reported to date, the heparin used was poorly contaminated and the exposure when using medical devices is less than direct injection heparin. Medtronic informed the customers concerned of the actions carried out on 16 May 2008. The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Extracorporeal Circulatory Circulation (ECC)
  • Modèle / numéro de série
  • Description du dispositif
    medical_device
  • Manufacturer
    MEDTRONIC

Manufacturer

MEDTRONIC
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    LAANSM