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U.S. healthcare regulators put their highest-risk Class I label on Medtronic's Paradigm insulin infusion pump recall.

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The FDA put its highest-risk label, Class I, on a recall of Medtronic's (NYSE:MDT) Paradigm insulin infusion pumps, which the medtech giant had warned about earlier this year.

Medtronic Canada said last month that it received 2 reports on its Paradigm and Polyfin infusion devices, concerning the over- and under-delivery of insulin therapy.

Medtronic informed patients, healthcare providers and pharmacies in Canada of the potential problem, to explain how to avoid it, according to the Brampton Guardian.

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