Device Recall Supreme Electrophysiology Extension Cable

  • Modelo / Serial
    Batch # 3334664
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.
  • Descripción del producto
    Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. || Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • 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