Device Recall iCAST and Advanta

  • Modelo / Serial
    Part Number 85455: Lots 240735, 240523;  Part Number 85355: Lot 240734
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
  • Descripción del producto
    Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) || Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85355 (Marketed OUTSIDE U.S. only) || The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA