Terumo Cardiovascular Systems
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Questions or concerns about the
Terumo CVS' Consent Decree?
Call 1.800.521.2818
(weekdays, 8am-6pm EST)
About Terumo CVS' Consent Decree
Compliance Reports
On March 29, 2011, Terumo Cardiovascular Systems (Terumo CVS) entered into a consent decree with the U.S. Food and Drug Administration (FDA).
As part of the consent decree, Terumo CVS promised to send compliance reports to each customer that signed a Certificate of Medical Necessity. The reports provide updates on the company's progress in fulfilling its commitments to the terms of the consent decree.
The reports will be released at scheduled intervals:
- March 29, 2012, one year after the decree was entered, and
- At six month intervals thereafter — until Terumo CVS has fulfilled its commitments to the consent decree and gained recertification.
Two-Year Compliance Report: March 29, 2013
- English (PDF)
- Dutch (PDF)
- French (PDF)
- German (PDF)
- Italian (PDF)
- Japanese (PDF)
- Mandarin (Simplified) (PDF)
- Mandarin (Traditional) (PDF)
- Portuguese (Brazilian) (PDF)
- Russian (PDF)
- Spanish (PDF)
Eighteen-Month Compliance Report: September 24, 2012
- English (PDF)
- Dutch (PDF)
- French (PDF)
- German (PDF)
- Italian (PDF)
- Japanese (PDF)
- Mandarin (Simplified) (PDF)
- Mandarin (Traditional) (PDF)
- Portuguese (Brazilian) (PDF)
- Russian (PDF)
- Spanish (PDF)
One-Year Compliance Report: March 29, 2012
- English (PDF)
- Dutch (PDF)
- French (PDF)
- German (PDF)
- Italian (PDF)
- Japanese (PDF)
- Mandarin (Simplified) (PDF)
- Mandarin (Traditional) (PDF)
- Portuguese (Brazilian) (PDF)
- Russian (PDF)
- Spanish (PDF)