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.
  • On February 25, 2015, the FDA notified Terumo CVS that the general Quality System and the CDI System 500 hardware were in compliance with FDA regulations, and that all injunctive restrictions were lifted from the CDI System 500 hardware. Read the press release.