Device Recall TheraSphere

Package Insert Number K120615-023, Rev 9.

Radiology Devices

3

Yes

Worldwide Distribution -- US (states of AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, RI, OH, OR, PA, WI) and country of Canada.

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.