Events

Avis De Sécurité sur HeartMate II and HeartMate XVE LVAS 12 Volt Sealed Lead Acid Battery Clips

Selon Swiss Agency for Therapeutic Products, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Switzerland qui a été fabriqué par Thoratec Corporation.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • ID de l'événement
    Vk_20091023_01
  • Date de publication de l'événement
    2009-10-26
  • Pays de l'événement
    Switzerland
  • Source de l'événement
    SATP
  • URL de la source de l'événement
    https://fsca.swissmedic.ch/mep/#?q=Vk_20091023_01
  • Notes / Alertes
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notes supplémentaires dans les données

Device

HeartMate II and HeartMate XVE LVAS 12 Volt Sealed Lead Acid Battery Clips
  • Modèle / numéro de série
    1237 | 458560206, 581080207
    581080507, 34331720107
    34404690108, 34532990109
    343317201407, 34331720207
    34331720507, 34404690208, 34404690308
    34404690408, 34432810108
    34450070108, 34477720108
    34570570109,34577730109
    34331720307 | manufactured and distributed
    between November 25, 2007 and October 5, 2009
  • Description du dispositif
    AIMD: Circulatory assist system
  • Manufacturer
    Thoratec Corporation

Manufacturer

Thoratec Corporation
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP