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.