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Medtronic Consent Decree Halts Routine Sales Of Synchromed II Pump

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.

Medtronic PLC has been ordered to stop making and distributing the Synchromed II implantable infusion pumps except in limited circumstances until the company corrects quality system violations in a complaint and consent decree between FDA and the firm, filed in U.S. District Court April 27.

The consent decree names the company and CEO S. Omar Ishrak and Medtronic Neuro President Thomas M. Tefft for violations that occurred at the Medtronic Neuromodulation facility in Columbia Heights,...

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