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Device Recall AFX2 Endovascular AAA System
Model / Serial
1594192 1594192R013 1590565 1590565014 1590565 1590565008 1520115 1520115008 1354739 1354739019 1354736 1354736002 1594192 1594192R014 1594192 1594192R010 1594192 1594192R009 1598697 1598697008 1598697 1598697003 1598697 1598697001 1594192 1594192R012 1594192 1594192R006 1590565 1590565009 1590565 1590565004 1590565 1590565002 1517329 1517329008 1517329 1517329006 1517329 1517329005 1516641 1516641008 1516641 1516641006 1472927 1472927006 1354745 1354745011 1354745 1354745009 1354740 1354740008 1354740 1354740002 1354739 1354739021 1354739 1354739017 1354739 1354739014 1354739 1354739010 1354739 1354739001 1578331 1578331008 1473420 1473420027 1613996 1613996014 1588687 1588687010 1588687 1588687007 1519368 1519368006 1517160 1517160008 1473420 1473420008 1586082 1586082001 1473420 1473420025 1613996 1613996015 1613996 1613996013 1613996 1613996012 1613996 1613996010 1613996 1613996007 1613996 1613996005 1613996 1613996003 1596669 1596669009 1596669 1596669005 1596669 1596669003 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1599015001 1613997 1613997011 1606030 1606030013 1606030 1606030008 1606030 1606030007 1606030 1606030006 1606030 1606030005 1604607 1604607036 1604607 1604607025 1604607 1604607021 1604607 1604607018 1604607 1604607014 1604607 1604607006 1604607 1604607005 1604607 1604607001 1599015 1599015016 1599015 1599015015 1599015 1599015014 1599015 1599015013 1599015 1599015010 1599015 1599015009 1599015 1599015007 1599015 1599015002 1594925 1594925001 1591279 1591279015 1591279 1591279008 1591279 1591279007 1591279 1591279004 1591128 1591128015 1591128 1591128012 1591128 1591128007 1591128 1591128005 1591128 1591128004 1591128 1591128003 1591128 1591128001 1587884 1587884009 1587884 1587884008 1587884 1587884005 1587884 1587884003 1581549 1581549011 1581549 1581549010 1564482 1564482006 1499830 1499830012 1499830 1499830009 1499830 1499830008 1484325 1484325008 1484325 1484325007 1484325 1484325004 1474668 1474668012 1474668 1474668001 1354867 1354867023 1354867 1354867017 1354867 1354867007 1354867 1354867002 1354863 1354863004 1354862 1354862028 1354862 1354862026 1354862 1354862025 1354862 1354862018 1354859 1354859021 1354859 1354859014 1354859 1354859004 1606030 1606030011 1604607 1604607035 1590360 1590360007 1596154 1596154010 1596154 1596154006 1590360 1590360014 1590360 1590360009 1531324 1531324003 1531324 1531324001 1519185 1519185013 1519185 1519185012 1519185 1519185005 1356501 1356501012 1356501 1356501010 1356501 1356501008 1356501 1356501001 1356499 1356499010 1579619 1579619011 1562393 1562393005 1356564 1356564010 1356560 1356560007 1605533 1605533009 1605533 1605533006 1586090 1586090003 1562393 1562393010 1472916 1472916009 1356565 1356565001 1356564 1356564024 1356561 1356561003 1551806 1551806014 1356566 1356566026 1613644 1613644013 1613644 1613644011 1613644 1613644008 1605533 1605533005 1605533 1605533002 1605533 1605533001 1592757 1592757R008 1588778 1588778008 1588778 1588778006 1588778 1588778002 1588778 1588778001 1586297 1586297008 1586297 1586297006 1586090 1586090015 1586090 1586090013 1586090 1586090009 1585827 1585827014 1585827 1585827008 1585827 1585827005 1585827 1585827002 1579619 1579619007 1579619 1579619006 1562393 1562393007 1562393 1562393004 1562393 1562393003 1562393 1562393002 1553665 1553665014 1553665 1553665013 1553665 1553665011 1553665 1553665010 1553665 1553665004 1553665 1553665002 1551806 1551806012 1551806 1551806009 1519370 1519370007 1519370 1519370002 1519370 1519370001 1499080 1499080005 1499067 1499067006 1499067 1499067004 1499067 1499067003 1484293 1484293022 1484293 1484293016 1484293 1484293014 1484293 1484293007 1472916 1472916011 1472915 1472915016 1472915 1472915004 1356566 1356566014 1356566 1356566013 1356565 1356565009 1356564 1356564017 1356564 1356564008 1356563 1356563001 1356562 1356562018 1356562 1356562013 1356560 1356560024 1356560 1356560013 1356560 1356560012 1605533 1605533010 1605533 1605533007 1553665 1553665009 1553665 1553665006 1499615 1499615004 1484295 1484295001 1474667 1474667009 1604742 1604742007 1587881 1587881013 1586982 1586982010 1484295 1484295005 1484275 1484275002 1484275 1484275001 1354929 1354929015 1354924 1354924022 1354927 1354927008 1354926 1354926012 1611875 1611875002 1605532 1605532014 1605532 1605532010 1605532 1605532007 1605532 1605532006 1604742 1604742008 1602400 1602400013 1602400 1602400010 1602400 1602400006 1596320 1596320014 1596320 1596320011 1596320 1596320008 1596320 1596320006 1596320 1596320003 1594391 1594391012 1594391 1594391008 1594391 1594391005 1593048 1593048R017 1593048 1593048R016 1593048 1593048R007 1593048 1593048R006 1593048 1593048R005 1593048 1593048R002 1593048 1593048R001 1590356 1590356013 1590356 1590356004 1590356 1590356002 1587881 1587881008 1587881 1587881001 1586982 1586982012 1586982 1586982007 1586982 1586982003 1547526 1547526011 1547526 1547526004 1499615 1499615014 1484295 1484295024 1484295 1484295015 1484295 1484295014 1354927 1354927025 1354927 1354927022 1354927 1354927010 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1593407 1593407R008 1593407 1593407R006 1553666 1553666013 1553666 1553666011 1519918 1519918013 1519918 1519918007 1612130 1612130007 1607214 1607214013 1606439 1606439013 1599391 1599391015 1599391 1599391009 1599391 1599391008 1599020 1599020014 1599020 1599020013 1599020 1599020005 1599020 1599020004 1599020 1599020003 1594920 1594920015 1594920 1594920009 1594920 1594920005 1593407 1593407R014 1593407 1593407R012 1593407 1593407R009 1593407 1593407R002 1588001 1588001001 1586134 1586134015 1586134 1586134014 1586134 1586134013 1586134 1586134008 1586134 1586134002 1580188 1580188003 1580188 1580188002 1580188 1580188001 1578544 1578544013 1578544 1578544012 1578544 1578544007 1578544 1578544004 1553666 1553666010 1553666 1553666009 1553666 1553666006 1516141 1516141040 1516141 1516141039 1516141 1516141038 1516141 1516141033 1516141 1516141005 1473692 1473692024 1473692 1473692004 1355104 1355104023 1355104 1355104017 1355104 1355104012 1355104 1355104009 1355103 1355103008 1355103 1355103002 1599391 1599391007 1599020 1599020010 1355165 1355165002 1355162 1355162003 1575320 1575320007 1538213 1538213007 1355165 1355165003 1355164 1355164002 1588656 1588656001 1580671 1580671008 1580671 1580671001 1575320 1575320009 1575320 1575320004 1538213 1538213015 1538213 1538213010 1538213 1538213009 1538213 1538213008 1538213 1538213002 1355165 1355165017 1355165 1355165013 1355165 1355165008 1355164 1355164012 1355164 1355164010 1355164 1355164003 1355162 1355162008 1355162 1355162007 1520117 1520117007 1356619 1356619014 1517063 1517063035 1356623 1356623006 1517063 1517063011 1356623 1356623005 1356619 1356619004 1592092 1592092R009 1592092 1592092R001 1520117 1520117011 1520117 1520117009 1520117 1520117004 1517063 1517063043 1517063 1517063042 1517063 1517063038 1517063 1517063031 1517063 1517063028 1517063 1517063021 1517063 1517063020 1517063 1517063007 1356623 1356623026 1356623 1356623024 1356623 1356623023 1356623 1356623017 1356623 1356623007 1356622 1356622013 1356622 1356622007 1356622 1356622006 1356622 1356622003 1356622 1356622002 1356622 1356622001 1356619 1356619037 1356619 1356619036 1356619 1356619035 1356619 1356619030 1356619 1356619028 1356619 1356619026 1356619 1356619020 1356619 1356619009 1356619 1356619008 1578543 1578543008 1578332 1578332006 1356685 1356685017 1356684 1356684002 1356681 1356681023 1606443 1606443006 1596540 1596540010 1553712 1553712009 1522145 1522145011 1613861 1613861005 1593190 1593190R007 1519685 1519685007 1514717 1514717006 1613926 1613926006 1613861 1613861004 1612047 1612047006 1612047 1612047004 1612047 1612047003 1612047 1612047001 1606443 1606443012 1606443 1606443009 1606443 1606443007 1604378 1604378014 1596540 1596540012 1596540 1596540009 1596540 1596540005 1596540 1596540002 1594558 1594558014 1594558 1594558012 1594558 1594558006 1594558 1594558002 1593190 1593190R020 1593190 1593190R018 1593190 1593190R014 1593190 1593190R009 1593190 1593190R008 1590769 1590769008 1590769 1590769004 1581296 1581296009 1581296 1581296008 1578543 1578543005 1578543 1578543002 1578543 1578543001 1553712 1553712012 1553712 1553712001 1519685 1519685020 1519685 1519685017 1519220 1519220001 1514717 1514717013 1514717 1514717002 1484324 1484324008 1484324 1484324001 1484323 1484323021 1484323 1484323016 1474001 1474001007 1463074 1463074007 1356685 1356685025 1356684 1356684001 1612047 1612047007 1612047 1612047005 1612047 1612047002 1593190 1593190R003 1590769 1590769002 1590769 1590769001 1578543 1578543004 1484338 1484338004 1355225 1355225023 1591826 1591826004 1575315 1575315004 1514898 1514898001 1355225 1355225017 1355225 1355225007 1591826 1591826011 1591826 1591826008 1591826 1591826006 1575315 1575315013 1575315 1575315005 1575315 1575315002 1524364 1524364012 1524364 1524364008 1524364 1524364007 1524364 1524364003 1514898 1514898013 1514898 1514898010 1514898 1514898006 1484339 1484339009 1484339 1484339006 1484339 1484339001 1484338 1484338011 1484338 1484338009 1355225 1355225028 1355225 1355225027 1355225 1355225019 1355225 1355225016 1355225 1355225011 1355225 1355225010 1355225 1355225002 1355224 1355224012 1355224 1355224010 1355285 1355285002 1601734 1601734006 1594809 1594809004 1594809 1594809003 1594809 1594809002 1526681 1526681014 1526681 1526681009 1526681 1526681007 1484345 1484345012 1355285 1355285010 1611800 1611800007 1592089 1592089R001 1491488 1491488012 1355347 1355347001 1355344 1355344005 1598770 1598770010 1598770 1598770007 1613380 1613380007 1613380 1613380004 1611800 1611800006 1611800 1611800002 1605223 1605223014 1605223 1605223013 1605223 1605223010 1605223 1605223009 1605223 1605223008 1605223 1605223007 1605223 1605223003 1605223 1605223002 1605223 1605223001 1598770 1598770015 1598770 1598770013 1598770 1598770012 1598770 1598770011 1598770 1598770005 1592089 1592089R014 1592089 1592089R010 1592089 1592089R007 1592089 1592089R005 1592089 1592089R002 1526848 1526848013 1526848 1526848010 1526848 1526848007 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1580675 1580675012 1517849 1517849014 1517849 1517849002 1515687 1515687013 1515687 1515687004 1515687 1515687003 1501763 1501763001 1484340 1484340008 1484340 1484340001 1355710 1355710030 1355710 1355710025 1355710 1355710018 1601730 1601730002 1595767 1595767012 1595767 1595767011 1578334 1578334004 1355771 1355771012 1355771 1355771005 1592094 1592094R009 1592094 1592094R006 1592094 1592094R004 1578334 1578334009 1578334 1578334005 1578334 1578334003 1578334 1578334002 1578334 1578334001 1538230 1538230012 1538230 1538230002 1355772 1355772011 1355772 1355772009 1355772 1355772001 1355771 1355771014 1355771 1355771009 1355892 1355892009 1355891 1355891012 1355891 1355891008 1355891 1355891006 1528914 1528914008 1528914 1528914007 1528914 1528914005 1528914 1528914002 1477298 1477298005 1356169 1356169006 1518970 1518970008 1518970 1518970009 1518970 1518970005 1356192 1356192004
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution - US (nationwide)and Internationally to Austria, Belgium, France, Germany, Greece, Italy, Ireland, Monaco, Poland Portugal, Romania, Spain, Sweden, Turkey, Israel, Argentina, Florida, Mexico, Chile, Brazil, Japan, Singapore, Malaysia, and Thailand.
Product Description
AFX2 Endovascular AAA System || Item No. Item Description || F00820-01 BEA28-120/I20-40 || F00820-02 BEA28-100/I20-40 || F00820-03 BEA28-80/I20-40 || F00820-06 BEA28-120/I16-40 || F00820-07 BEA28-100/I16-40 || F00820-08 BEA28-80/I16-40 || F00820-09 BEA28-60/I16-40 || F00820-16 BEA28-110/I20-30 || F00820-17 BEA28-90/I20-30 || F00820-18 BEA28-70/I20-30 || F00820-20 BEA28-110/I16-30 || F00820-21 BEA28-90/I16-30 || F00820-22 BEA28-70/I16-30 || F00820-28 BEA25-120/I20-40 || F00820-29 BEA25-100/I20-40 || F00820-30 BEA25-80/I20-40 || F00820-43 BEA25-110/I20-30 || F00820-44 BEA25-90/I20-30 || F00820-45 BEA25-70/I20-30 || F00820-57 BEA22-80/I20-40 || F00820-71 BEA22-90/I20-30 || F00820-72 BEA22-70/I20-30 || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Manufacturer
Endologix
1 Event
Recall of Device Recall AFX2 Endovascular AAA System
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Manufacturer
Endologix
Manufacturer Address
Endologix, 35 Hammond, Irvine CA 92618-1607
Manufacturer Parent Company (2017)
Endologix Inc.
Source
USFDA
Language
English
Français
Español
한국어