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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 670G Insulin Pump

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  Class 2 Device Recall MiniMed 670G Insulin Pump see related information
Date Initiated by Firm March 15, 2021
Create Date June 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-1772-2021
Recall Event ID 87735
Product Classification Automated insulin dosing device system, single hormonal control - Product Code OZP
Product MiniMed 670G Insulin Pump:
PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿
PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿
PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿
PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿
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 CLIN 020 MM;¿
PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿
Code Information 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; NG1980358H; NG1687895H; NG1845348H; NG1515522H; NG1989568H; NG1664835H; NG1687590H; NG1521244H; NG1518680H; NG1845336H; NG1541279H; NG1678117H; NG1583283H; NG1678052H; NG1900511H; NG1557933H; NG1522551H; NG1989328H; NG1677959H; NG1619151H; NG2020233H; NG1687538H; NG1691272H; NG1769679H; NG1770742H; NG1892553H; NG1899866H; NG1734464H; NG1715477H; NG2205686H; NG1895702H; NG1645142H; NG1635968H; NG1988768H; NG1645489H; NG1978813H; NG1560443H; NG1981421H; NG1661791H; NG2020194H; NG1830292H; NG1571454H; NG1529995H; NG1732392H; NG1988894H; NG1734149H; NG1705568H; NG2001506H; NG2133145H; NG1566844H; NG2001705H; NG1769959H; NG2007384H; NG1689978H; NG2079428H; NG1998282H; NG1521933H; NG1661863H; NG1527016H; NG1639334H; NG2020733H; NG1678143H; NG1888661H; NG1831185H; NG1735485H; NG1660784H; NG1770168H; NG1744077H; NG1712833H; NG1644254H; NG1989763H; NG1769732H; NG1734455H; NG1637534H; NG1734237H; NG2126358H; NG1830684H; NG1997599H; NG1560448H; NG2001226H; NG1845240H; NG1898254H; NG1560453H; NG2198521H; NG1711902H; NG1713359H; NG1678107H; NG1733739H; NG1899959H; NG1571867H; NG2002716H; NG2002627H; NG1770225H; NG1535863H; NG1734329H; NG1560317H; NG1557010H; NG1698332H; NG1991560H; NG1612912H; NG2235556H; NG1830412H; NG1667558H; NG2002878H; NG1734460H; NG1732229H; NG1900461H; NG1734572H; NG1885324H; NG1700100H; NG1690976H; NG1769643H; NG1568929H; NG2090376H; NG2020677H; NG1734278H; NG2145326H; NG1664883H; NG1886585H; NG2006696H; NG1830399H; NG2007569H; NG2004925H; NG1734424H; NG1689346H; NG1688027H; NG1560531H; NG2003663H; NG1762691H; NG1646167H; NG1831146H; NG1991791H; NG1896425H; NG1994374H; NG1734497H; NG2197725H; NG1715908H; NG1896591H; NG1831317H; NG1830990H; NG1769748H; NG1896199H; NG1639037H; NG2009438H; NG1707750H; NG1830587H; NG1549706H; NG2075718H; NG1522231H; NG1663249H; NG1925089H; NG2205901H; NG1831173H; NG2001796H; NG1830500H; NG1707975H; NG1734409H; NG1637186H; NG2007951H; NG1895223H; NG2181482H; NG1708324H; NG1880826H; NG1735615H; NG1734355H; NG1734503H; NG1661436H; NG2020354H; NG1983668H; NG1712427H; NG1997734H; NG2000326H; NG1857310H; NG1522127H; NG1991448H; NG2020536H; NG1998106H; NG1734310H; NG1614414H; NG1522253H; NG1830661H; NG1988828H; NG1951930H; NG1521399H; NG1560423H; NG1977085H; NG1937507H; NG1670064H; NG1820456H; NG1830431H; NG2150594H; NG1548483H; NG1582377H; NG1660313H; NG1893936H; NG1845452H; NG1661289H; NG1581427H; NG1845269H; NG1705558H; NG1660563H; NG1669110H; NG2004567H; NG1517803H; NG1734489H; NG1837391H; NG1830643H; NG1706273H; NG1830572H; NG1687400H; NG1887820H; NG2126128H; NG1560351H; NG1857611H; NG1770176H; NG1645304H; NG2005019H; NG1520492H; NG2126163H; NG1706230H; NG1532750H; NG1880500H; NG1950744H; NG2134429H; NG1668352H; NG1667979H; NG1734730H; NG1709388H; NG2003446H; NG1998185H; NG2020433H; NG1551987H; NG1734737H; NG1559177H; NG1987266H; NG1593943H; NG1668642H; NG1899058H; NG1830747H; NG1678019H; NG1734366H; NG1593521H; NG1999201H; NG1831145H; NG1987577H; NG2000264H; NG1896524H; NG1678099H; NG1731673H; NG2001689H; NG1769957H; NG2020680H; NG1570174H; NG1908773H; NG1522123H; NG1769647H; NG1515091H; NG1734597H; NG1734986H; NG1677964H; NG1663199H; NG1896596H; NG1939461H; NG1880050H; NG2083369H; NG1660443H; NG1736069H; NG1893914H; NG1696709H; NG1570393H; NG1769960H; NG2006782H; NG1924962H; NG1736251H; NG1638579H; NG1619498H; NG1660673H; NG1564267H; NG1697980H; NG1558326H; NG1531924H; NG1686835H; NG1770572H; NG1560478H; NG2020280H; NG1734608H; NG1744878H; NG2077427H; NG2192805H; NG1845147H; NG1760924H; NG1830599H; NG1705850H; NG1989385H; NG2205791H; NG1672846H; NG2003214H; NG2001876H; NG1552913H; NG1528321H; NG1830609H; NG1931482H; NG1677898H; NG1644692H; NG1560445H; NG1983600H; NG2007968H; NG1560420H; NG1830780H; NG1868571H; NG1660303H; NG1983813H; NG1831221H; NG1518170H; NG1987673H; NG1515163H; NG1522430H; NG2020411H; NG1736028H; NG1583844H; NG2003044H; NG1560385H; NG1770949H; NG1908683H; NG2126089H; NG2004358H; NG2020185H; NG1688989H; NG1885071H; NG1898496H; NG1555637H; NG1560450H; NG1932490H; NG1561734H; NG1522388H; NG1932138H; NG1769790H; NG1734185H; NG1734565H; NG2001362H; NG1830493H; NG2003979H; NG1732045H; NG1557974H; NG1769846H; NG1845358H; NG1560827H; NG2004647H; NG2236300H; NG1525059H; NG2020534H; NG2150867H; NG1687862H; NG1565059H; NG1569340H; NG1560473H; NG2009339H; NG1528369H; NG1560388H; NG1985128H; NG2205648H; NG1542120H; NG1900572H; NG1981609H; NG1714898H; NG2238458H; NG1731777H; NG1714642H; NG1531772H; NG1715445H; NG1775342H; NG1769953H; NG1696949H; NG1715554H; NG1895779H; NG1551293H; NG1986583H; NG1845314H; NG1896349H; NG1560338H; NG1521935H; NG2006945H; NG1735778H; NG1734443H; NG1643962H; NG1660951H; NG1769712H; NG1699988H; NG1734215H; NG1734511H; NG2151742H; NG1678160H; NG1560499H; NG1734538H; NG1898200H; NG1531866H; NG1560424H; NG1983541H; NG1830579H; NG1579839H; NG1769663H; NG2205608H; NG2138952H; NG1944748H; NG1560452H; NG1560468H; NG1893151H; NG1637198H; NG1557031H; NG2127099H; NG2005025H; NG1661858H; NG1570755H; NG1660721H; NG2235999H; NG1560391H; NG1736061H; NG1958952H; NG1900430H; NG2181473H; NG1697527H; NG1895840H; NG2079122H; NG1522408H; NG1734974H; NG1999070H; NG1770029H; NG2006933H; NG1998216H; NG1977278H; NG2077662H; NG1932484H; NG1993340H; NG1830462H; NG1734571H; NG1898343H; NG2205872H; NG1734994H; NG1987334H; NG1678146H; NG1734434H; NG1938429H; NG1560441H; NG1998923H; NG1830611H; NG1988924H; NG1639842H; NG1565642H; NG1899902H; NG1540087H; NG1678113H; NG1997983H; NG1996470H; NG1995959H; NG1892710H; NG1705394H; NG1989304H; NG1532486H; NG1734211H; NG1734265H; NG1617337H; NG1732590H; NG2003338H; NG1522089H; NG1989671H; NG1637472H; NG1734408H; NG1734517H; NG1731917H; NG1661070H; NG1603911H; NG1830373H; NG1994162H; NG1968795H; NG1560487H; NG2020359H; NG1560455H; NG1677928H; NG1994850H; NG1769801H; NG1638140H; NG1660409H; NG2008044H; NG1522417H; NG1690951H; NG2192645H; NG1560320H; NG1560460H; NG1732486H; NG2134014H; NG1665439H; NG1702786H; NG1810017H; NG1830670H; NG1732186H; NG1743037H; NG1698282H; NG1830540H; NG1898379H; NG1711424H; NG2020613H; NG1769995H; NG1830362H; NG1615943H; NG1830201H; NG1908549H; NG1831211H; NG1898283H; NG1734691H; NG1559062H; NG1660930H; NG1734540H; NG1678175H; NG1942020H; NG1734567H; NG1831030H; NG1705144H; NG1989350H; NG1978973H; NG1560301H; NG1522997H; NG1677980H; NG1558416H; NG1715309H; NG1909769H; NG1993997H; NG1992175H; NG1560398H; NG1899217H; NG1990480H; NG1734446H; NG2004373H; NG1677962H; NG1560563H; NG1830703H; NG1678007H; NG1831271H; NG1845290H; NG1830697H; NG1999459H; NG1987446H; NG1556604H; NG1989753H; NG1668797H; NG1894871H; NG1542033H; NG2003443H; NG1697513H; NG1944822H; NG2205635H; NG1985021H; NG1895614H; NG2020245H; NG1877851H; NG1661750H; NG1532824H; NG1678026H; NG1735340H; NG1560295H; NG1703886H; NG1845225H; NG1895510H; NG1594926H; NG1734530H; NG1769655H; NG1909471H; NG1573321H; NG1569347H; NG1820527H; NG2020742H; NG1597902H; NG1939503H; NG1689975H; NG2207554H; NG1560483H; NG1988240H; NG1983521H; NG1830653H; NG1678163H; NG1522670H; NG1559706H; NG1732183H; NG1981696H; NG1570620H; NG1991768H; NG1998832H; NG1517002H; NG1560422H; NG1560511H; NG1663155H; NG1665028H; NG1938436H; NG1735612H; NG1831312H; NG1830637H; NG1927226H; NG1830593H; NG2006974H; NG1830513H; NG1734674H; NG2078446H; NG1548779H; NG2020673H; NG1655669H; NG1734771H; NG1732245H; NG1995978H; NG1830806H; NG1713389H; NG1893597H; NG1571756H; NG1686676H; NG1712976H; NG1900254H; NG1594004H; NG1733914H; NG1994145H; NG1830402H; NG1559200H; NG1646218H; NG1560513H; NG1984479H; NG2205613H; NG1845221H; NG1678048H; NG1555932H; NG1550224H; NG1560345H; NG1560474H; NG1845378H; NG1987709H; NG1678001H; NG1678075H; NG1530326H; NG1678094H; NG1734568H; NG1994739H; NG1560393H; NG1716952H; NG2214564H; NG2002329H; NG1700529H; NG1704316H; NG2078088H; NG1983618H; NG1845379H; NG1997918H; NG2003064H; NG1959109H; NG1831176H; NG1689480H; NG1560476H; NG1987415H; NG1734767H; NG2020446H; NG1898502H; NG2002705H; NG2003031H; NG1560512H; NG2020525H; NG1619644H; NG1981253H; NG1769859H; NG1736236H; NG1979320H; NG1734461H; NG1760094H; NG1830537H; NG1716353H; NG1516509H; NG1525351H; NG1710922H; NG1689964H; NG1996830H; NG1908967H; NG1991783H; NG1678053H; NG1552295H; NG1881288H; NG1688442H; NG1830750H; NG1735692H; NG2002258H; NG1806200H; NG2074631H; NG1733851H; NG1560378H; NG1735771H; NG1522549H; NG1551661H; NG1669124H; NG1996904H; NG1731954H; NG1669038H; NG1579465H; NG1733812H; NG1521103H; NG1667624H; NG1735613H; NG1700505H; NG1734410H; NG2213253H; NG1734195H; NG1557987H; NG2181437H; NG1987965H; NG1743377H; NG1579660H; NG1560440H; NG1909917H; NG1734470H; NG1663931H; NG1899564H; NG1950670H; NG1734551H; NG1734926H; NG1836414H; NG2193446H; NG1716398H; NG1734539H; NG2161250H; NG1661747H; NG1560520H; NG1990430H; NG1677542H; NG1529069H; NG1574472H; NG1736073H; NG1570943H; NG1845132H; NG1687397H; NG1760350H; NG1715259H; NG1714445H; NG1518290H; NG1993854H; NG1732102H; NG1830606H; NG1830465H; NG1541710H; NG1678155H; NG1900588H; NG1997169H; NG1938619H; NG1677894H; NG1998123H; NG1661792H; NG1880970H; NG1735039H; NG1931424H; NG1869241H; NG1910491H; NG1696842H; NG1708002H; NG1830830H; NG2002642H; NG2002951H; NG1830210H; NG1990421H; NG1636030H; NG1831318H; NG1696903H; NG1898479H; NG1678095H; NG1998671H; NG1880551H; NG1559160H; NG1938271H; NG1619326H; NG1696789H; NG1898233H; NG1769978H; NG1551960H; NG1568400H; NG1996016H; NG1895575H; NG2020710H; NG1560407H; NG1678154H; NG1769791H; NG1560444H; NG2020216H; NG1898209H; NG1668038H; NG1999252H; NG1522077H; NG1734345H; NG1769951H; NG1687698H; NG1769878H; NG1856374H; NG2007077H; NG2005222H; NG1977584H; NG1735767H; NG1983532H; NG1561171H; NG1712285H; NG1734592H; NG1999036H; NG1519067H; NG1769707H; NG1705150H; NG1665487H; NG1989324H; NG1514619H; NG1971727H; NG1743085H; NG1983827H; NG1831105H; NG2077605H; NG2205626H; NG1732133H; NG1830575H; NG1522456H; NG1732828H; NG1519932H; NG1830239H; NG1926648H; NG1731833H; NG1616093H; NG2152220H; NG1752662H; NG2002106H; NG2143888H; NG1995034H; NG1995098H; NG1687971H; NG1845275H; NG1830541H; NG1997840H; NG1677872H; NG2006110H; NG1677885H; NG1665563H; NG1677994H; NG1989713H; NG1662503H; NG1830796H; NG1710863H; NG1734712H; NG2001354H; NG1669891H; NG1613315H; NG1734354H; NG1669301H; NG1645644H; NG2126222H; NG1893806H; NG2073980H; NG1977572H; NG1851999H; NG1899945H; NG1592742H; NG1705665H; NG1555541H; NG1615035H; NG1579659H; NG1770183H; NG2005515H; NG1646139H; NG2020721H; NG2020451H; NG2020665H; NG1705070H; NG1931251H; NG1987779H; NG2005078H; NG1697955H; NG2181009H; NG1984341H; NG1988323H; NG1572587H; NG2001673H; NG2020353H; NG1574713H; NG1677773H; NG1594954H; NG1532204H; NG1830660H; NG1830474H; NG1772408H; NG1734252H; NG1540755H; NG1990365H; NG1769918H; NG1662507H; NG2004849H; NG1521322H; NG2206077H; NG2182256H; NG1558385H; NG1984053H; NG1560557H; NG1734586H; NG1769826H; NG1519637H; NG2152276H; NG1996353H; NG1845470H; NG1999003H; NG1734583H; NG1522813H; NG2020398H; NG1677972H; NG1732659H; NG1710947H; NG1664795H; NG2125411H; NG1527220H; NG1665060H; NG1899800H; NG1734512H; NG1637923H; NG2007045H; NG1735561H; NG1678157H; NG1984178H; NG1993385H; NG1868716H; NG1718132H; NG1691004H; NG1895664H; NG1568623H; NG1734634H; NG2004416H; NG1850858H; NG1557788H; NG1761657H; NG1619577H; NG1668507H; NG1559590H; NG1560484H; NG2005526H; NG1769737H; NG1637405H; NG2004963H; NG1713878H; NG1583519H; NG2126276H; NG1678044H; NG2006707H; NG1561262H; NG1677795H; NG2154590H; NG1668048H; NG1713211H; NG1540449H; NG1998569H; NG1993378H; NG1687495H; NG1560469H; NG1845486H; NG1717237H; NG2000832H; NG1613071H; NG1988745H; NG1645283H; NG2083477H; NG1735230H; NG1660071H; NG1560472H; NG1769800H; NG1579811H; NG1718233H; NG1678016H; NG1715226H; NG1856534H; NG1885952H; NG1893700H; NG1830666H; NG1518215H; NG1678171H; NG1898241H; NG1926808H; NG1895571H; NG1769682H; NG1677983H; NG1769962H; NG1662211H; NG1565201H; NG1519002H; NG1735490H; NG2020376H; NG1662464H; NG1558263H; NG1845292H; NG1734522H; NG2002006H; NG1751943H; NG1712135H; NG1532653H; NG1556455H; NG2144148H; NG1519670H; NG1660722H; NG1991244H; NG1660642H; NG1898337H; NG1551190H; NG1926972H; NG1736017H; NG1735053H; NG1663922H; NG1830585H; NG1677918H; NG1750585H; NG2002378H; NG1898385H; NG2020465H; NG1559071H; NG1522453H; NG2082398H; NG1586880H; NG2206065H; NG1895480H; NG1519095H; NG1672750H; NG1560488H; NG1543110H; NG1735360H; NG1716465H; NG1988285H; NG1560340H; NG1560454H; NG1678158H; NG1830507H; NG2004739H; NG1663870H; NG1560605H; NG1705168H; NG1900562H; NG1573438H; NG1687707H; NG1831051H; NG1537445H; NG1996172H; NG1731821H; NG1896172H; NG1614202H; NG1711741H; NG1991595H; NG2001596H; NG1556430H; NG1690119H; NG1994704H; NG1896191H; NG1734012H; NG2003054H; NG1930927H; NG2182379H; NG1549486H; NG1743403H; NG1762645H; NG1696673H; NG2182219H; NG1619902H; NG1989152H; NG2018987H; NG1742834H; NG1880486H; NG1916276H; NG2207068H; NG2076280H; NG1899892H; NG1845377H; NG1734271H; NG1997909H; NG1699255H; NG1851671H; NG1678101H; NG2000287H; NG2008103H; NG1616032H; NG2000500H; NG1560475H; NG1705413H; NG1524717H; NG1570375H; NG1564541H; NG2173598H; NG1868837H; NG1909007H; NG1637655H; NG1938768H; NG1732119H; NG1638838H; NG2078640H; NG2020521H; NG2012618H; NG1830394H; NG1769606H; NG1908541H; NG1636906H; NG1770174H; NG1893699H; NG1519563H; NG1532911H; NG1989689H; NG2205660H; NG1769796H; NG1899198H; NG1932062H; NG1987226H; NG1977989H; NG1571824H; NG1732325H; NG1898422H; NG2004283H; NG1540972H; NG1932012H; NG1998326H; NG1677943H; NG1593243H; NG1830418H; NG1516074H; NG1678111H; NG1662216H; NG1560505H; NG1998655H; NG1715524H; NG1830612H; NG1925786H; NG1830567H; NG1522521H; NG1711922H; NG1735526H; NG1698438H; NG1830656H; NG1926579H; NG1994505H; NG1678086H; NG2000528H; NG1908788H; NG1547541H; NG1895706H; NG1580433H; NG2205715H; NG1915538H; NG1522523H; NG1524159H; NG1984872H; NG1925753H; NG2008131H; NG1769719H; NG2020715H; NG1520477H; NG2214347H; NG1735211H; NG1560477H; NG2003794H; NG1830473H; NG1831186H; NG1769708H; NG1660385H; NG1734467H; NG1731764H; NG1709144H; NG1941977H; NG1645794H; NG1662273H; NG1994447H; NG1900360H; NG1699429H; NG1522315H; NG2205623H; NG1736093H; NG2003829H; NG1660119H; NG1900573H; NG1713932H; NG1996314H; NG1661071H; NG1597445H; NG1989322H; 
Recalling Firm/
Medtronic Minimed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action On 03/15/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE CORRECTION" Notification via regionally approved methods (e.g. email, registered mail, courier, hand delivery) informing customers that their insulin pump with software version 6.5 that could present pump errors after delivering a large bolus under certain conditions. These errors may occur if All the following conditions are met: 1-The bolus delivery speed is programmed to Quick in the pump settings (default is Standard). 2-The SmartGuard" feature is in use. 3-The pump needs to be on the bolus delivery screen when an auto correction bolus is triggered. Auto corrections are triggered when sensor glucose (SG) is running high and Active Insulin is low. 4-The bolus amount programmed to be delivered is greater than 17.1U. Note: This can be a single bolus greater than 17.1U or a combination of boluses totaling greater than 17.1U. If all the above conditions are met, within 2 minutes of bolus delivery completion, the pump initiates Pump error 53, followed by Pump error 23 alarm. Upon clearing the pump errors, the pump resets and indicates Active Insulin has been cleared. The pump then guides the user to resume operation in Manual Mode. The SmartGuard" status screen indicates the warm-up period has started. After approximately 5 hours, the SmartGuard" feature will be available. Since Active Insulin will display 0.0 units in the pump after experiencing the pump errors above, 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, which may result in low blood sugar (hypoglycemia) or severe hypoglycemia. In rare cases, severe hypoglycemia, if left untreated, may lead to a life-threatening situation. As of January 21, 2021, Medtronic has received no reports of serious patient harm or serious injury related to this issue. Customers are instructed to: If their pump screen indicates that Active Insulin has cleare
Quantity in Commerce U.S. Investigational Clinical Study = 1,266 devices
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, Sweden, Switzerland, Turkey, and United Kingdom
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.