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# FDA Lifts Portion of Terumo Consent Decree
- URL: https://www.fdaweb.com/fda-lifts-portion-of-terumo-consent-decree/
- Published: 2016-06-10T12:00:00.000Z
- Updated: 2026-09-14T21:08:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135901

FDA has told Terumo Cardiovascular Systems that it has successfully completed its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, MI manufacturing facility, including Terumo Advanced Perfusion System 1, that were impacted by a 2011 consent decree. As a result, all shipping restrictions that were imposed under the decree are now lifted, the company says.  
  
Under the decree, FDA prohibited the manufacture and distribution of two heart-lung bypass systems and other cardiovascular devices to new customers ([see story](http://www.fdaweb.com/login.php?sa=v&aid=D5117747&searchWords=terumo&cate=S&stid=%241%24AZ5.Jq5.%24tuvRK9tLfXDwyB1GTnwAb%2F)). It also restricted sale of the systems to existing customers until the company complies with FDA Current Good Manufacturing Practice and Medical Device Reporting requirements. Additionally, Terumo agreed to pay the federal government $35 million in disgorgement of profits derived from past sales.

In a 6/8 letter, 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.” The letter came on the heels of a May inspection that found no inspectional observations.

Terumo completed the first phase of a two-phase work plan 12/2014\. After a subsequent inspection of the facility, FDA determined 2/2015 that the Ann Arbor plant’s general Quality Management System, as well as processes specific to its CDI Blood Parameter Monitors, were in compliance with regulations and it lifted shipping restrictions on the monitors, the company says. It completed the second and final phase of its work plan in February, leading to the agency’s inspection in May.

Terumo says it will “resume distribution of its monitoring systems this summer and expects to scale up production of its heart-lung machines after it completes several engineering projects to manage obsolescence issues.”