Events

Recall of Device Recall TheraSphere

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MDS Canada Inc. DBA MDS Nordion.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51701
  • Event Risk Class
    Class 3
  • Event Number
    Z-1325-2009
  • Event Initiated Date
    2009-02-24
  • Event Date Posted
    2009-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81031
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    microspheres radionuclide - Product Code NAW
  • Reason
    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.
  • 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.

Device

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.
  • Manufacturer
    MDS Canada Inc. DBA MDS Nordion

Manufacturer

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