Class 2 Device Recall MiniMed 670G Insulin Pump

• Date Initiated by Firm: March 15, 2021
• Create Date: June 01, 2021
• Recall Status: Open, 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: 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
• 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; 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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
• Recalling Firm/ Manufacturer: Medtronic Minimed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Pamela Reese; 818-576-3398
• 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: 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.