Extracorporeal Membrane Oxygenation Support for Postcardiotomy Cardiogenic Shock in Adult Patients: Predictors of In-Hospital Mortality and Failure to be Weaned from Extracorporeal Membrane Oxygenation

During an inspection last year at Terumo Cardiovascular Systems Ann Arbor, Mich., plant, FDA officials found numerous violations to good manufacturing practice and medical device reporting requirements. On March 17, Terumo executive officers signed a consent decree of permanent injunction and under its terms, Terumo will pay almost $35 million in profits from past sales to the federal government.