International Medical Devices Database

Manufacturer Address
MDS Canada Inc. DBA MDS Nordion, 447 March Road, Ottawa Canada Ontario
Manufacturer Parent Company (2017)
Nordion (Canada) Inc
Source
USFDA
1 Event
- Recall of Device Recall TheraSphere

One device in the database

Device Recall TheraSphere

Model / Serial
Package Insert Number K120615-023, Rev 9.
Product Classification
Radiology Devices
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.

One manufacturer with a similar name

Learn more about the data here

MDS Canada Inc. DBA MDS Nordion

Manufacturer Address
MDS Canada Inc. DBA MDS Nordion, 447 March Road, Kanata Canada
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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