FDAFDA · Food and drugs·Recall number Z-1049-2017
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
Published January 25, 2017 · Recall initiated: January 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endologix
- Distributor
- 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.
- Lot
- 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 1593387 1593387R018 1593387 1593387R016 1593387 1593387R013 1593387 1593387R008 1593387 1593387R004 1591299 1591299013 1591299 1591299011 1588774 1588774013 1588774 1588774011 1588774 1588774009 1586082 1586082014 1586082 1586082013 1586082 1586082008 1586082 1586082007 1586082 1586082006 1579770 1579770011 1579770 1579770008 1578331 1578331010 1578331 1578331006 1578331 1578331005 1578331 1578331004 1562573 1562573015 1562573 1562573014 1562573 1562573013 1562573 1562573011 1562573 1562573010 1517160 1517160003 1473690 1473690028 1354810 1354810007 1354808 1354808010 1354808 1354808001 1354806 1354806017 1354804 1354804011 1354804 1354804007 1354804 1354804004 1354804 1354804002 1354801 1354801008 1484325 1484325003 1354867 1354867016 1354865 1354865021 1354859 1354859020 1604607 1604607038 1604607 1604607032 1604607 1604607030 1604607 1604607002 1594925 1594925003 1594925 1594925002 1591128 1591128013 1564482 1564482003 1522241 1522241010 1354865 1354865027 1354859 1354859017 1599015 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 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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