Device Recall S.M.A.R.T. CONTROL Transhepatic Biliary Stent

  • Modèle / numéro de série
    Catalog Numbers: C09080MB, C09080SB, C10080MB, C10080SB, C12030MB, C12030SB, C12040MB, C12040SB, C12060MB, C12060SB, C12080MB, C12080SB, C14030MB, C14030SB, C14040MB, C14040SB, C14060MB, C14060SB, C14080MB, C14080SB.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - USA, and the countries of Japan, Canada, Mexico, South Korea, and Taiwan.
  • Description du dispositif
    S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree. || Model numbers are CxxyyyMB, CxxyyySB, CxxyyyML, and CxxyyySL, where xx is the stent diameter in mm and yyy is the stent length in mm; but not including catalogs where yyy is 120 or 150. The Removal only includes Catalog Numbers in the above sequence with S.M.A.R.T¿ CONTROL in the logo/description. All unexpired lot numbers 15112447 through 15525516.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Société-mère du fabricant (2017)
  • Source