Medtronic Inc. recalls MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for c…

Recall date

April 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0517-2021

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 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.