Terumo Cardiovascular Group
- About Consent Decree
- Progress Report
- Fact Sheet
- Frequently Asked Questions
- Status of Terumo CVS Products
- Glossary of Related Terms
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About Terumo CVS' Consent Decree
Consent Decree Fact Sheet
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.
In a letter dated June 8, 2016, the FDA concluded: "Terumo is no longer enjoined under Paragraph 5 of the Consent Decree from manufacturing, packing, storing, installing, and/or distributing the above listed products from the Ann Arbor Facility."
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.
Consent Decree Background
- On March 22, 2011, Terumo CVS announced that it 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. The decree went into effect on March 29, 2011.
- In the medical device industry, a consent decree is an agreement between the FDA and a device manufacturer that defines the terms under which the company can continue to conduct business while it addresses the FDA's concerns.
- The consent decree is in response to concerns raised by the FDA regarding the processes and procedures used by Terumo CVS to manufacture products at its Ann Arbor factory. The FDA noted its concerns during earlier inspections of the facility.
- The key terms of the consent decree were:
- Terumo CVS would develop a work plan to resolve deficiencies noted in an independent audit of its Quality System. Terumo CVS would submit the plan to the FDA for approval. Terumo CVS' progress would be documented by an independent auditor on a regular basis.
- Until Terumo CVS completes the actions in the plan, it agreed to restrict distribution of certain products built at its Ann Arbor factory to existing customers who deem the products medically necessary.
- Terumo CVS agrees to pay the FDA a disgorgement of $35 million.
- All other Terumo CVS products are exempt from the consent decree and are available without restriction, including:
- Terumo CVS products manufactured at its other facilities in Ashland, Massachusetts, and Elkton, Maryland, including, but not limited to: oxygenators, perfusion circuits, shunt sensors and cuvettes for CDI® Blood Parameter Monitoring Systems, Sarns™ Disposable Centrifugal Pumps and others.
- Products manufactured by third parties, but distributed by Terumo CVS.
- Products manufactured by any other Terumo entity.
- The consent decree did NOT require Terumo CVS to remove, recall or perform any corrective actions on the products currently in clinical use (or in inventory) at customer facilities.
- Now that restrictions are lifted, Terumo CVS will fully exit the consent decree after five years of surveillance inspections that demonstrate sustained compliance.
Consent Decree Timeline
- March 2011: Terumo CVS enters into consent decree with the FDA.
- Dec. 2014: Terumo CVS completes the first phase of a two-phase work plan.
- Jan. 2015: The FDA issues no investigational observations after its subsequent inspection.
- Feb. 2015: The FDA informs Terumo CVS that Ann Arbor's general Quality Management System, as well as processes specific to its CDI Blood Parameter Monitors, are in compliance with regulation. The FDA lifts shipping restrictions on the monitors.
- Feb. 2016: Terumo CVS completes the second phase of the work plan.
- May 2016: The FDA issues no investigational observations after its subsequent inspection.
- June 2016: The FDA informs Terumo CVS that processes related to the remaining products manufactured in Ann Arbor are in compliance with regulation. The FDA lifts shipping restrictions on remaining products.