Terumo Cardiovascular Systems

Progress Report

On March 29, 2011, Terumo Cardiovascular Systems entered into a consent decree with the U.S. Food and Drug Administration (FDA) to address deficiencies in the Quality System at its Ann Arbor plant. Since then, the company has made steady progress fulfilling its commitments to the terms of the decree.

Since mid-summer 2011, Terumo CVS has been focused on designing and building a new Quality System, a large-scale project and the core of its ongoing work. 

Milestones to-date:

  • Terumo CVS  implemented its new Quality System and began the final stages of preparing for a series of audits by its third-party expert. After review and correction of any audit findings, it will achieve recertification.
  • Terumo CVS reviewed and remediated its records on past compliance-related decisions and activities, such as product complaints, and the company's response to them.
  • At professional conferences and in-person meetings, Terumo CVS  updated more than 500 of its customers on its progress toward building a new Quality System.
  • Terumo CVS has notified all customers who signed a Certificate of Medical Necessity of the status of its recertification work one year, and again at eighteen months after the consent decree was agreed, as required by FDA.