FDA recall Z-0110-2018

Medtronic Inc. · Class II · device

Product

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)

Reason for recall

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

Distribution

Worldwide

Key facts

Status
Ongoing
Initiation date
2017-09-10
Report date
2017-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northridge, CA, United States

Primary source

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