Terumo To Pay $35M Over Heart Device Violations

Law360, New York (March 23, 2011, 7:33 PM EDT) -- Terumo Cardiovascular Systems Corp. will forfeit $35 million in profits and cease production of several cardiovascular devices to resolve allegations in Michigan that it violated manufacturing and medical device reporting standards, the U.S. Food and Drug Administration said Tuesday.

As part of a consent decree to resolve a case in the U.S. District Court for the Eastern District of Michigan, Terumo is prohibited from manufacturing and distributing two heart-lung bypass systems — its Terumo Advanced Perfusion System 1 and Sarns Modular Perfusion System 8000 — as...
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