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FDA warns Terumo over heart-lung machine

This article was originally published in Clinica

Executive Summary

Terumo Cardiovascular Systems, the Ann Arbor, Michigan-based cardiac surgery arm of Japanese medical products group Terumo, has received a warning letter from the US FDA. The agency says the company failed to report promptly on an investigation into 12 malfunctions of the manual pump speed control knob on its heart-lung machine, Advanced Perfusion System 1.

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