Medical device recalls Moderate risk

Medtronic Inc. recalls MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these…

Recall date
January 31, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1890-2017
FDA classification
Class II
Brand / firm
Medtronic Inc.
Sold / distributed
Europe, Australia, Japan, Singapore

Why it was recalled

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.

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 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.

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