September 21, 2021
Tokyo - Terumo Corporation (TSE: 4543) 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 Rob 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."
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.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 25,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
Corporate Communication Dept., Terumo Corporation
Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition.
Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.