Medical device recalls Moderate risk

Medtronic Inc. recalls MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the cont…

Recall date
April 30, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0518-2021
FDA classification
Class II
Brand / firm
Medtronic Inc.
Sold / distributed
Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.

Why it was recalled

Missing solder battery connection, which could interrupt power of insulin pump.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

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