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U.S. Department of Health and Human Services

Class 3 Device Recall TheraSphere

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  Class 3 Device Recall TheraSphere see related information
Date Initiated by Firm February 24, 2009
Date Posted June 05, 2009
Recall Status1 Terminated 3 on June 08, 2009
Recall Number Z-1325-2009
Recall Event ID 51701
HDE Number H980006 
Product Classification microspheres radionuclide - Product Code NAW
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.
Code Information Package Insert Number K120615-023, Rev 9.
Recalling Firm/
Manufacturer		 MDS Canada Inc. DBA MDS Nordion
447 March Road
Ottawa Canada Ontario
For Additional Information Contact Janet Bukovcan
613-592-3400 Ext. 2306
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 26
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
HDE Database HDEs with Product Code = NAW and Original Applicant = Boston Scientific Corporation
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