Device Recall TheraSphere

  • Model / Serial
    Package Insert Number K120615-023, Rev 9.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.
  • Product Description
    TheraSphere Administration Set (Part Number K125914-034). || TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    MDS Canada Inc. DBA MDS Nordion, 447 March Road, Ottawa Canada Ontario
  • Manufacturer Parent Company (2017)
  • Source
    USFDA