FDA-Device2020-12-09Class II

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.

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
2
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0518-2021

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