Terumo Cardiovascular Group

Questions or concerns about the Terumo CVS' Consent Decree?

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About Terumo CVS' Consent Decree

Status of Terumo CVS Products

Terumo Cardiovascular Systems (Terumo CVS) received notice from the U.S. Food and Drug Administration (FDA) that it successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, Michigan, manufacturing facility, including Terumo® Advanced Perfusion System 1.

This follows the February 2015 notification that the general Quality Systems and the CDI® Blood Parameter Monitoring System 500 hardware were in compliance with the FDA regulations.

As a result, all shipping restrictions imposed as a term of its 2011 consent decree are lifted.

Throughout the consent decree, Terumo products manufactured outside of the Ann Arbor facility were exempt from the consent decree and have been available without restriction. This includes:

  • Terumo CVS products manufactured at its other factories in Ashland, Massachusetts, and Elkton, Maryland
  • Products manufactured by third parties, but distributed by Terumo CVS
  • Products manufactured by any other Terumo entity

Please note: During consent decree remediation activities, resources that were previously dedicated to product engineering projects were shifted to remediation activities to expedite lifting shipping restrictions. Now those resources are shifting back to the engineering projects that must be completed in order to ship product.

CDI® Blood Parameter Monitoring System 500:

Terumo CVS is resuming distribution of the CDI Blood Parameter Monitoring System 500 — this is happening today. The CDI System 500 is the world's most trusted and used continuous in-line blood gas monitor, and the company is working to stabilize product supply to help ensure the best patient care.

Terumo® Advanced Perfusion System 1:

Terumo CVS expects to scale up production of Terumo System 1 after it completes the required engineering projects. Your Terumo Sales Representative can provide specific details about system availability for your region. While Terumo System 1 availability may not be immediate, Terumo CVS is fully committed to returning this life-sustaining product to cardiac surgery teams around the world.