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Medtronic Consent Decree Halts Routine Sales Of Synchromed II Pump

This article was originally published in The Gray Sheet

Executive Summary

Medtronic and its CEO S. Omar Ishrak and Medtronic Neuro President Thomas M. Tefft entered into a consent decree with FDA over quality system violations for its Synchromed II infusion pumps, and must stop making, designing and distributing them except when medically necessary.

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