The Recall Desk

FDA (Devices) recall action 87735

Medtronic Minimed recalled 2 products on 2021-06-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-06-09
Critical
0
Units
16,948

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-06-09

    MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

    A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

    Product
    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 0
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2021-06-09

    MiniMed 780G Insulin Pump Software Fault Risks Overdose

    A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.

    Product
    MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-18
    Category
    Distribution
    12 states