Device Recall SteeroCathDx Diagnostic Catheter

  • Modelo / Serial
    Model Numbers M0042027BL0 (Lot#: 0011092878, 0011092882, 0011107097) and M0042028BL0 (Lot#: 0011036506, 0011036507, 0011036585, 0011036586, 0011043535, 0011043537, 0011046910, 0011046913, 0011049772, 0011049773, 0011054879, 0011055000, 0011059409, 0011059410, 0011061991, 0011061992, 0011065023, 0011065024, 0011069509, 0011069510, 0011073729, 0011073730, 0011078604, 0011078605, 0011081318, 0011081445, 0011083742, 0011083743, 0011087354, 0011087355, 0011088108, 0011088109, 0011096360)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia.
  • Descripción del producto
    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Boston Scientific Corp, 150 Baytech Drive, San Jose CA 95134
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA