Recall Z-1771-2021— Medtronic Minimed

Class II FDA medical device recall by Medtronic Minimed, initiated 2021-03-15. FDA's recall record names no specific 510(k) clearance for this event. 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-1886XC 780G V6.5 CLIN MG;¿ PUMP MMT-1885L MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886L MM780G 6.5W BLE MG;¿ KIT MMT-1896ES MM780G V6.5W MG;¿ KIT MMT-1896WWA MM780G BLE MG ES;¿ KIT MMT-1895WWA MM780G BLE MMOL AR;¿ KIT MMT-1895WWA MM780G BLE MMOL CS;¿ KIT MMT-1895WWA MM780G BLE MMOL DA;¿ KIT MMT-1895WWA MM780G BLE MMOL DE;¿ KIT MMT-1895WWA MM780G BLE MMOL EN;¿ KIT MMT-1895WWA MM780G BLE MMOL FI;¿ KIT MMT-1895WWA MM780G BLE MMOL FR;¿ KIT MMT-1895WWA MM780G BLE MMOL IT;¿ KIT MMT-1895WWA MM780G BLE MMOL NL;¿ KIT MMT-1895WWA MM780G BLE MMOL NO;¿ KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV;¿ KIT MMT-1895WWA MM780G BLE MMOL HU;¿ KIT MMT-1896WWA MM780G BLE MG AR;¿ KIT MMT-1896WWA MM780G BLE MG DE;¿ KIT MMT-1896WWA MM780G BLE MG EL;¿ KIT MMT-1896WWA MM780G BLE MG HE;¿ KIT MMT-1896WWA MM780G BLE MG IT;¿ KIT MMT-1896WWA MM780G BLE MG PL;¿ KIT MMT-1896WWA MM780G BLE MG RO;¿ KIT MMT-1896WWA MM780G BLE MG TR;¿ KIT MMT-1896WWA MM780G BLE MG NL;¿ KIT MMT-1896WWA MM780G BLE MG FR;¿ KIT MMT-1896WWA MM780G BLE MG ES;. Reason: 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..

Recalling firm

Medtronic Minimed

Classification

Class II

Status

Ongoing

Initiated

2021-03-15

Firm location

Northridge, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.