FDA-Device2017-05-10Class II

MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.

Medtronic Inc.
Hazard

Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.

Sold states
Europe, Australia, Japan, Singapore
Affected count
42,215 units
Manufactured in
18000 Devonshire Street, Northridge, CA, United States
Products
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1890-2017

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