FDA-Device2020-12-09Class II
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.
Medtronic Inc.
Hazard
Missing solder battery connection, which could interrupt power of insulin pump.
Sold states
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.
Affected count
206
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0517-2021Don't want to check this manually?
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