Terumo Cardiovascular Group

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 factory. Since then, the company has made steady progress fulfilling its commitments to the terms of the decree.

Milestones to-date:

  • Terumo CVS notified all customers who signed a Certificate of Medical Necessity of the status of its certification work one year after the decree was entered and at six-month intervals thereafter, as required by the FDA.
  • 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 reviewed and remediated its records on past compliance-related decisions and activities, such as product complaints, and the company's response to them.
  • Terumo CVS implemented its new Quality System and completed a rigorous series of audits to test the new system.
  • In April 2014, FDA informed Terumo CVS that it would need to make some further corrections to its Quality System before FDA lifts the shipping restrictions. Terumo CVS submitted a Work Plan in May 2014, and FDA approved the Work Plan in June 2014. Read the July 2014 Consent Decree Update (PDF).