Terumo Cardiovascular Group

About Terumo Cardiovascular Systems' Consent Decree

On March 22, 2011, Terumo Cardiovascular Systems (Terumo CVS) announced that it had agreed on the terms of a consent decree with the U.S. Food and Drug Administration (FDA) regarding improvements to the Quality System at the company’s Ann Arbor, Michigan factory. See media release. The decree went into effect on March 29, 2011.

This website is intended to provide useful information about the terms of the consent decree and updates on Terumo CVS’ progress in fulfilling its obligations under the terms.

It is important to understand:

  • Terumo CVS is committed to resolving FDA’s concerns — quickly and completely.  See Progress Report.
  • Terumo CVS customers can continue to use its products with confidence during the period of the consent decree.  Terumo CVS products continue to be used in more than 1,000 life-saving surgical procedures every day. Neither FDA nor Terumo is recommending that customers stop using these products.
  • Terumo CVS is committed to its customers and the cardiac surgery community. It is significantly investing in building a world-class Quality System at its Ann Arbor factory, and continues its investments in customer education, product development, and customer support.
  • Terumo CVS will remain an important member of the southeast Michigan business and life sciences communities as it completes the terms of the consent decree. The company will continue to contribute to the local economy where it is located by providing high quality jobs, hiring local suppliers, and supporting community activities.

NOTE: to individuals who are participating, or considering participation in, a clinical trial involving a Terumo product: no products in any Terumo clinical trials are subject to the consent decree.