Medtronic Minimed recalls MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP…

Recall date

March 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1772-2021

FDA classification

Class II

Brand / firm

Medtronic Minimed

Sold / distributed

U.S.(Clinical): AR, CA, CO, CT, FL, GA, ID, MI, MN, TN, TX, and WA O.U.S.: Austria, Bahrain, Belgium, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Liechtenstein, Luxembourg, Malta, Martinique,…

Why it was recalled

Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

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 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS;¿ PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1742KX 670G V6.1 MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿