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;¿ PUM
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain MiniMed 780G insulin pump models due to a software design issue that can cause a software fault when a large bolus is delivered at quick bolus speed. If a user is unaware of the amount of active insulin in the pump after this occurs, they may deliver an additional bolus, creating a risk of insulin overdose. The affected devices include models MMT-1885, MMT-1886, MMT-1895WW, MMT-1896WW, and several variants, with 15,682 devices distributed outside the United States across multiple countries including Austria, Belgium, France, Germany, Italy, Spain, and others, as well as clinical distribution in 12 U.S. states.
The recall record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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, Netherlands, New Caledonia, Norway, Poland, Qatar, Reunion, Romania, Slovenia, South Africa, Spain, S Quantity: O.U.S. Distibution only = 15,682 devices Lot/code info: Model#(CFN)/UDI-DI(GTIN): MMT-1885/00763000384258;¿ MMT-1886/00763000384265;¿ MMT-1895WW/00763000384272;¿ MMT-1896WW/00763000384289;¿ MMT-1884XC/ 00763000455613;¿ MMT-1885XC/00763000421939;¿ MMT-1886XC/00763000421946;¿ MMT-1885L/00763000441432;¿ MMT-1886L/00763000441449;¿ MMT-1896ES/00763000454296;¿ MMT-1896WWA/00763000411541;¿ KIT MMT-1895WWA/00763000411374;¿ KIT MMT-1895WWA/00763000411381;¿ KIT MMT-1895WWA/00763000411398;¿ KIT MMT-1895WWA/00763000411404;¿ KIT MMT-1895WWA/00763000411411;¿ KIT MMT-1895WWA/00763000411428;¿ KIT MMT-1895WWA/00763000411435;¿ KIT MMT-1895WWA/00763000411459;¿ KIT MMT-1895WWA/00763000411466;¿ KIT MMT-1895WWA/00763000411473;¿ KIT MMT-1895WWA/00763000411497;¿ KIT MMT-1895WWA/00763000411503;¿ KIT MMT-1895WWA/00763000420703;¿ KIT MMT-1895WWA/00763000411510;¿ KIT MMT-1895WWA/00763000411527;¿ KIT MMT-1895WWA/00763000411534;¿ KIT MMT-1895WWA/00763000411565;¿ KIT MMT-1895WWA/00763000411572;¿ KIT MMT-1895WWA/00763000411596;¿ KIT MMT-1895WWA/00763000411619;¿ KIT MMT-1895WWA/00763000411626;¿ MMT-1896WWA/00763000411589;¿ MMT-1896WWA/00763000411558;¿ MMT-1896WWA/00763000411541; Serial Numbers: NG2357677H; NG2377469H; NG2377947H; NG2377975H; NG2378041H; NG2386393H; NG2386401H; NG2386405H; NG2386654H; NG2396576H; NG2397715H; NG2397806H; NG2397932H; NG2408853H; NG2412686H; NG2427129H; NG2428794H; NG2428917H; NG2482370H; NG2482577H; NG2482589H; NG2357431H; NG2357433H; NG2357436H; NG2357444H; NG2357448H; NG2357449H; NG2357452H; NG2357455H; NG2357460H; NG2357463H; NG2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.