FDA Announces Terumo Consent Decree

The FDA Tuesday announced that Ann Arbor, Mich-based cardiovascular devicemaker Terumo has signed a consent decree of permanent injunction with the FDA. The consent decree “prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices” to new and existing customers until Terumo complies with the FDA’s cGMP and MDR requirements, according to the announcement. Terumo must also pay the federal government $35 million of its past sales.