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 67
Check against the official notice below — it lists the full affected range.
Medtronic is recalling specific MiniMed 670G Insulin Pump models due to a software design issue. When a large bolus delivery is completed at quick bolus speed, a software fault may occur that prevents the pump from properly displaying the amount of active insulin in the user's system. If a user is unaware of how much insulin is already active and delivers an additional bolus, there is a risk of receiving too much insulin. The recalled devices were distributed in the United States through clinical investigational studies in twelve states, as well as internationally in numerous countries. A total of 1,266 devices were involved in the U.S. clinical study.
The recall affects specific model numbers and serial numbers listed in the distribution records. According to the recall record provided, no remedy is specified for affected consumers.
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: U.S. Investigational Clinical Study = 1,266 devices Lot/code info: Model #(CFN)/¿UDI-DI(GTIN): MMT-1740K/00763000258429;¿ MMT-1740KX/00763000408909;¿ MMT-1741KFX/00763000303556;¿ MMT-1741KFX/00763000408930;¿ MMT-1741KX/00763000258436;¿ MMT-1741KX/00763000408916;¿ MMT-1741KXS/00763000258443;¿ MMT-1741KXS/00763000408923;¿ MMT-1742KX/00763000157456;¿ MMT-1742KX/00763000250232;¿ MMT-1742KX/00763000258467;¿ MMT-1742KX/00763000408954;¿ MMT-1742KX/00763000408947; Serial Numbers: NG1522406H; NG1698348H; NG2078422H; NG1586805H; NG1997312H; NG1829832H; NG1662936H; NG2127163H; NG1899556H; NG1687796H; NG1830512H; NG1560426H; NG1998243H; NG1984224H; NG1556256H; NG1998843H; NG1522295H; NG1937812H; NG1541556H; NG1829747H; NG2062114H; NG1531199H; NG1570173H; NG1713497H; NG2006526H; NG2006970H; NG1733793H; NG2006078H; NG1703340H; NG2020531H; NG1898154H; NG1932186H; NG2001204H; NG1733151H; NG1700186H; NG1731830H; NG1831300H; NG1995586H; NG2003110H; NG1830451H; NG1900348H; NG1830644H; NG1686683H; NG1560375H; NG1899052H; NG1769848H; NG1734425H; NG2150522H; NG1560333H; NG2004999H; NG1550073H; NG1522162H; NG1522678H; NG1568972H; NG1678021H; NG1981394H; NG1560462H; NG1699654H; NG1678012H; NG1900389H; NG1687745H; NG1677866H; NG1736029H; NG2205804H; NG1560439H; NG1645132H; NG1560368H; NG1899999H; NG1951752H; NG2009281H; NG1589435H; NG1560296H; NG1750717H; NG2009597H; NG1998935H; NG1696555H; NG1900504H; NG1678015H; NG2020687H; NG1663944H; NG1830364H; NG1830064H; NG1830568H; NG1937509H; NG1732015H; NG1735756H; NG1581605H; NG2126328H; NG1986702H; NG1983861H; NG1663422H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.