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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1039-2017

AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Publicado el 25 de enero de 2017 · Inicio del retiro: 27 de diciembre de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Endologix
Distribuidor
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Lote
"AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1298056012 1354736007 1354737005 1354738002 1354739002 1354739008 1354739020 1354739027 1354740011 1354745005 1354798002 1354798008 1354798014 1354799004 1354800001 1354800008 1354800014 1354801006 1354801013 1354802004 1354802010 1354804006 1354806001 1354806007 1354806019 1354806026 1354807003 1354807009 1354808003 1354808009 1354809009 1354809015 1354810008 1354810015 1354810022 1354859002 1354859009 1354859016 1354859025 1354860005 1354861001 1354861008 1354861014 1354861021 1354861027 1354862004 1354862011 1354862017 1354862027 1354863007 1354865009 1354865017 1354865025 1354867004 1354867012 1354867020 1354867028 1354921006 1354922002 1354922010 1354922018 1354922024 1354923002 1354923009 1354923015 1354923021 1354924003 1354924012 1354924018 1354924026 1354925005 1354925012 1354925018 1354925024 1354926005 1354926013 1354926020 1354926026 1354927006 1354927019 1354927029 1354928007 1354929005 1354929011 1354980004 1354981001 1354981008 1354982003 1354982010 1354983015 1355041003 1355041011 1355041020 1355042001 1355042008 1355042015 1355042021 1355042027 1355043010 1355044004 1355044013 1355044023 1355047007 1355102002 1355102008 1355102014 1355103009 1355103015 1355103021 1355103029 1355104006 1355104016 1355104024 1355105007 1355106001 1355106007 1355106013 1355162005 1355163005 1355163011 1355164007 1355165006 1355165019 1355224004 1355224011 1355224018 1355224027 1355225006 1355225018 1355285001 1355285008 1355344002 1355344010 1355345007 1355345013 1355346005 1355346011 1355347004 1355347010 1355404009 1355404017 1355404024 1355405005 1355405019 1355405028 1355407005 1355407015 1355407023 1355467003 1355467010 1355468002 1355468009 1355469006 1355469014 1355469021 1355470002 1355470009 1355470016 1355470024 1355471002 1355471009 1355472003 1355472012 1355472021 1355473001 1355473008 1355473015 1355473026 1355474007 1355475003 1355475012 1355526005 1355527004 1355528003 1355528011 1355528021 1355588002 1355588008 1355589009 1355589017 1355590001 1355590009 1355591001 1355591008 1355591014 1355592012 1355649003 1355649009 1355710003 1355710009 1355710017 1355710024 1355711004 1355771003 1355771013 1355830004 1355830010 1355830016 1355830025 1355831011 1355831020 1355831030 1355832008 1355832015 1355891005 1355929003 1355930001 1355930007 1355930014 1355931007 1355931013 1355931020 1355931027 1355932005 1355932014 1355932023 1355933002 1355933011 1355934005 1355934011 1355934022 1355989005 1355989012 1355989023 1355990002 1355990014 1356048009 1356048015 1356048023 1356048030 1356049007 1356049013 1356049020 1356050001 1356050007 1356050014 1356053006 1356053013 1356054007 1356054015 1356055006 1356056002 1356056009 1356109003 1356109010 1356110001 1356110008 1356169003 1356220002 1356220009 1356220017 1356220024 1356221004 1356221010 1356221017 1356221024 1356222001 1356222009 1356222018 1356222027 1356281005 1356281011 1356282004 1356282013 1356282020 1356282026 1356283003 1356283011 1356498001 1356498007 1356498013 1356499006 1356499013 1356501009 1356560006 1356560015 1356560025 1356561005 1356562003 1356562009 1356562019 1356562025 1356563003 1356563009 1356564002 1356564009 1356564018 1356564025 1356565003 1356565010 1356565016 1356565023 1356565029 1356566007 1356566016 1356566023 1356566031 1356619010 1356619019 1356619029 1356619040 1356621001 1356621007 1356622011 1356623010 1356623018 1356681006 1356681012 1356681018 1356681025 1356682004 1356682010 1356683001 1356683007 1356683013 1356683019 1356683026 1356684004 1356684011 1356685003 1356685011 1356685019 1356742001 1356742008 1356803007 1356803014 1356804005 1356805002 1
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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