Terumo CVS Fully Exits Consent Decree

Tokyo — Terumo Corporation (TSE: 4543 Section 1) announced today that the Ann Arbor plant of its U.S. subsidiary, Terumo Cardiovascular Systems (hereafter Terumo CVS) is no longer under a consent decree with the United States federal government.

After a review of Terumo CVS’s sustained compliance and upon mutual agreement that the company had successfully met all terms of its Consent Decree, the United States Food and Drug Administration (FDA) and the Department of Justice agreed on August 31, 2021, that Terumo CVS could file an unopposed motion to vacate the Consent Decree.

On September 13, 2021, the United States District Court granted Terumo CVS’ motion and vacated the consent decree under which the company had been operating since 2011.

Throughout the rigorous journey to complete its consent decree work plan, Terumo Cardiovascular continually reinforced its commitment to patient safety and product quality.

“As we look toward our future, we remain steadfastly committed to our customers and patients, and our corporate mission to contribute to society through healthcare,” said Robert DeRyke, President and CEO of Terumo Cardiovascular. “We will use the lessons learned and systems we have built to deliver world class products with the highest levels of quality. We will leverage our quality-first culture to drive further improvements in product quality, to support new product launches, and to meet and exceed our customers’ expectations.”

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The Ann Arbor plant of Terumo Cardiovascular Systems Corporation, located in Michigan, U.S.A., produces hardware products including heart-lung machines and intraoperative monitoring systems for cardiac surgery. Terumo’s Ashitaka plant in Japan (Shizuoka) and Elkton plant in U.S.A. (Maryland), which produce disposable products that account for the majority of sales in Cardiovascular Business of Terumo group, were unaffected by the activities related to the consent decree.