Product Safety Recalls

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Medtronic Minimed Recall 87735

Description: 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 670G V6.3 SF MG CLIN IS;¿ 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 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿

Medtronic Minimed Recall 87735 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1772-2021
Event ID87735
Event DescriptionMiniMed 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 670G V6.3 SF MG CLIN IS;¿ 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 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿
Product TypeDevices
DistributionU.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
QuantityU.S. Investigational Clinical Study = 1,266 devices
Recall ReasonDue 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.
Device Classification20210609
Device Code InfoModel #(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; 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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;
Center Classification Date20210601
Recall Initiation Date20210315
Recalling FirmMedtronic Minimed
Initial Notification E-Mail
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