MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario
Lot Codes / Batch Numbers
Package Insert Number K120615-023, Rev 9.
Products Sold
Package Insert Number K120615-023, Rev 9.
MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario is recalling TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation tr due to Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device.
Recommended Action
Per FDA guidance
A User Bulletin (TS-2009-1) dated February 23, 2009 was issued to all TheraSphere user sites. The bulletin described the issue, affected units, and recommended actions for users. The bulletin instructed users on the proper use of the pinch clamp. MDS Nordion also updated the package insert with these instructions. For questions about the recall, customers in North America contact MDS Nordion Customer Service at 1-866-363-3330 and customers outside North America call 1-877-474-5999 and request Customer Service. Customers may also e-mail MDS Nordion at TheraSphere@mdsinc.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, FL, IL, IN, KS, MD, MI, NC, OH, OR, PA, RI, WI
Page updated: Jan 10, 2026