Device Recall Edwards Lifesciences Crimpers

  • Modelo / Serial
    Models 9100CR26, all lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Descripción del producto
    Edwards Lifesciences Crimpers, Model 9100CR26. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Models 9100CR23, all lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.
  • Descripción del producto
    Edwards Lifesciences Crimpers, Model 9100CR23. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.
  • Manufacturer