Implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy devices (CRT-D)

  • Modelo / Serial
  • Descripción del producto
    Models containing the affected battery design are:Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra, ICD and CRT-D.Family UK model numbers UK launch Fortify CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, Q1 2010 Fortify CD2233-40, CD2233-40Q, CD2235-40, CD2235-40Q Q1 2010 Unify CD3235-40, CD3235-40Q, CD3251-40, CD3251-40Q Q1 2010 Assura CD3267-40, CD3267-40Q, CD3261-40, CD3261-40Q Q1 2012 Assura CD3361-40, CD3361-40C, CD3361-40Q, CD3361-40QC Q1 2012 Assura CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC Q1 2012 Assura CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Q1 2012 Assura CD2259-40, CD2259-40Q, CD1259-40, CD1259-40Q Q1 2012 Assura CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC Q1 2012 Assura CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC Q1 2012
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Vicki Snow Snr Quality & Regulatory Manager, UK & Ireland St. Jude Medical UK Limited Capulet House Stratford Business and Technology Park Banbury Road Stratford-upon-Avon CV37 7GX Telephone: 01789 207 637Email:
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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