FDA-Device2017-11-29Class II

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

Medtronic Inc.
Hazard

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Sold states
Worldwide
Affected count
1,513,530 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0110-2018

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