Device Recall FastCath" Transseptal Guiding Introducer

  • Modelo / Serial
    Model no. 406586 Batch no. 3619533
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution only including the states of FL, KY and OK.
  • Descripción del producto
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 || Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 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