| Class 2 Device Recall AFX Endovascular AAA System | |
Date Initiated by Firm | December 27, 2016 |
Date Posted | January 19, 2017 |
Recall Status1 |
Terminated 3 on April 28, 2017 |
Recall Number | Z-1039-2017 |
Recall Event ID |
76113 |
PMA Number | P040002 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
|
Product | 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). |
Code Information |
"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 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1356928029 1356929011 1356929019 1356929029 1356987007 1356987014 1356988009 1356989001 1356989008 1463073003 1463073010 1463074008 1463075005 1463076001 1463076010 1463077007 1469330005 1469330015 1469330024 1472915007 1472915014 1472916005 1472916013 1472917004 1472917011 1472917018 1472917025 1472921007 1472921017 1472921028 1472922009 1472924005 1472927002 1472928002 1472928009 1472928015 1473420007 1473420014 1473420020 1473690001 1473690007 1473690014 1473690020 1473690026 1473692005 1473692011 1473692017 1473692023 1473996004 1473996011 1474001002 1474001010 1474667001 1474667012 1474668005 1474668013 1476187005 1476187014 1476188008 1477297001 1477298004 1481015009 1481015015 1484273008 1484273014 1484277008 1484284001 1484284009 1484286001 1484286010 1484291005 1484291014 1484293005 1484293015 1484293024 1484295006 1484295018 1484295027 1484320006 1484320020 1484322001 1484322010 1484323009 1484323015 1484323023 1484324003 1484324011 1484325006 1484325014 1484338015 1484339010 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1593517R018 1594192R001 1594391015 1594558005 1594769002 1594920007 1595287007 1595477004 1595571006 1595698003 1595767009 1596271012 1596421009 1596540013 1596669012 1599015008 1599354004 1601731004 1601735004 1602400014 1604378002 1604607028 1606029005 1607095008 Lot Codes 1354736003 1354737001 1354737007 1354738004 1354739004 1354739012 1354739023 1354740003 1354745001 1354745008 1354798004 1354798010 1354798016 1354799006 1354800003 1354800010 1354801002 1354801009 1354801015 1354802006 1354803002 1354804010 1354806003 1354806009 1354806021 1354806028 1354807005 1354807011 1354808005 1354809002 1354809011 1354810003 1354810010 1354810017 1354810024 1354859005 1354859011 1354859019 1354860001 1354860007 1354861003 1354861010 1354861016 1354861023 1354861030 1354862006 1354862013 1354862021 1354863002 1354863010 1354865013 1354865019 1354865028 1354867006 1354867014 1354867022 1354867030 1354921008 1354922004 1354922012 1354922020 1354922026 1354923004 1354923011 1354923017 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1578544003 1578544014 1578810007 1579488002 1579488013 1579615004 1579615014 1579618009 1579619009 1579770007 1579781007 1579967007 1579973002 1580188005 1580291002 1580540012 1580671006 1580675004 1581019008 1581294010 1581296006 1581505001 1581549007 1581647002 1585766008 1585827012 1585831006 1586082005 1586132001 1586134009 1586297009 1586982013 1587881011 1587884006 1588006002 1588487009 1588526001 1588687003 1588774003 1588774014 1590356005 1590360016 1590565010 1590751001 1590769005 1590769013 1591128009 1591279009 1591670002 1592089R011 1592469R017 1593107R005 1593387R002 1593387R015 1593517R002 1593674R014 1594192R002 1594392005 1594558008 1594769007 1594920008 1595287009 1595477005 1595672002 1595698004 1595767014 1596320002 1596540001 1596669001 1596669013 1599015011 1599397012 1601731009 1601735015 1602401001 1604378005 1604607029 1606169001 1607095009 Lot Codes 1354736004 1354737002 1354737008 1354738005 1354739005 1354739013 1354739024 1354740005 1354745002 1354745010 1354798005 1354798011 1354799001 1354799007 1354800004 1354800011 1354801003 1354801010 1354802001 1354802007 1354803003 1354804012 1354806004 1354806010 1354806023 1354806029 1354807006 1354807013 1354808006 1354809003 1354809012 1354810004 1354810011 1354810018 1354810025 1354859006 1354859012 1354859022 1354860002 1354860008 1354861004 1354861011 1354861017 1354861024 1354862001 1354862007 1354862014 1354862022 1354863003 1354863011 1354865014 1354865020 1354865029 1354867008 1354867015 1354867024 1354921001 1354921009 1354922007 1354922013 1354922021 1354922027 1354923005 1354923012 1354923018 1354923024 1354924006 1354924015 1354924021 1354925001 1354925009 1354925015 1354925021 1354926002 1354926008 1354926017 1354926023 1354927003 1354927014 1354927024 1354928003 1354929001 1354929008 1354980001 1354980011 1354981004 1354981013 1354982007 1354982014 1354985005 1355041008 1355041016 1355041023 1355042005 1355042012 1355042018 1355042024 1355043005 1355043013 1355044009 1355044017 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1356863018 1356863030 1356864008 1356864014 1356926005 1356926011 1356926018 1356927002 1356927008 1356927016 1356928003 1356928010 1356928019 1356928026 1356929004 1356929016 1356929023 1356987003 1356987011 1356988004 1356988012 1356989004 1356989014 1463073006 1463074003 1463075002 1463075008 1463076007 1463077004 1469330002 1469330010 1469330018 1472915003 1472915011 1472916002 1472916008 1472917001 1472917007 1472917014 1472917021 1472921003 1472921011 1472921025 1472922005 1472924001 1472924011 1472927007 1472928005 1472928012 1473420003 1473420011 1473420017 1473420023 1473690004 1473690010 1473690017 1473690023 1473692001 1473692008 1473692014 1473692020 1473692027 1473996007 1473996014 1474001006 1474001013 1474667005 1474667015 1474668009 1476187001 1476187011 1476188004 1476189002 1477297004 1481015004 1481015012 1484273005 1484273011 1484277004 1484277012 1484284005 1484285004 1484286004 1484286015 1484291009 1484293002 1484293009 1484293019 1484293028 1484295011 1484295021 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1562573007 1562589004 1562589014 1562591015 1564482009 1566566010 1568633001 1568633007 1575122006 1575125013 1575320001 1577574002 1577574013 1577575010 1578069003 1578331007 1578332008 1578333007 1578543014 1578544006 1578810002 1578810010 1579488005 1579613004 1579615007 1579618003 1579618011 1579619013 1579770013 1579781010 1579972010 1579973004 1580188010 1580291008 1580583006 1580671010 1580675011 1581294004 1581296001 1581296011 1581549003 1581549009 1581647010 1585766013 1585827015 1585831011 1586082015 1586134003 1586134012 1586982001 1587881004 1587881014 1587884010 1588006010 1588493001 1588526005 1588687005 1588774006 1588778004 1590360006 1590360018 1590587002 1590751008 1590769007 1591097005 1591279001 1591279011 1591670007 1592089R013 1593048R015 1593107R007 1593387R006 1593407R015 1593517R014 1594191r003 1594391006 1594392011 1594558013 1594769012 1594925004 1595287012 1595477008 1595675003 1595725007 1596154005 1596421001 1596540007 1596669006 1598770006 1599020006 1601729001 1601733001 1602400008 1602401010 1604607003 1604631006 1607095002 Lot Codes 1354736006 1354737004 1354738001 1354738007 1354739007 1354739016 1354739026 1354740009 1354745004 1354798001 1354798007 1354798013 1354799003 1354799009 1354800006 1354800013 1354801005 1354801012 1354802003 1354802009 1354804005 1354804014 1354806006 1354806018 1354806025 1354807002 1354807008 1354808002 1354808008 1354809006 1354809014 1354810006 1354810014 1354810021 1354859001 1354859008 1354859015 1354859024 1354860004 1354860010 1354861006 1354861013 1354861020 1354861026 1354862003 1354862010 1354862016 1354862024 1354863006 1354865001 1354865016 1354865024 1354867003 1354867010 1354867019 1354867027 1354921005 1354922001 1354922009 1354922016 1354922023 1354923001 1354923008 1354923014 1354923020 1354924001 1354924010 1354924017 1354924024 1354925003 1354925011 1354925017 1354925023 1354926004 1354926011 1354926019 1354926025 1354927005 1354927017 1354927028 1354928005 1354929004 1354929010 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1356283002 1356283010 1356283020 1356498006 1356498012 1356499005 1356499012 1356501006 1356560004 1356560014 1356560023 1356561004 1356562001 1356562008 1356562017 1356562024 1356563002 1356563008 1356564001 1356564007 1356564016 1356564023 1356565002 1356565008 1356565015 1356565022 1356565028 1356566006 1356566015 1356566022 1356566030 1356619006 1356619017 1356619027 1356619039 1356620005 1356621006 1356622010 1356623009 1356623016 1356681005 1356681011 1356681017 1356681024 1356682003 1356682009 1356682015 1356683006 1356683012 1356683018 1356683025 1356684003 1356684010 1356685002 1356685010 1356685018 1356685024 1356742007 1356803006 1356803013 1356804004 1356805001 1356805008 1356805014 1356805021 1356805028 1356806005 1356806012 1356806023 1356807001 1356807010 1356807016 1356807024 1356808005 1356808012 1356808018 1356808025 1356863004 1356863012 1356863023 1356864002 1356864010 1356926001 1356926007 1356926013 1356926020 1356927004 1356927010 1356927019 1356928005 1356928013 1356928022 1356928028 1356929010 1356929018 1356929027 1356987005 1356987013 1356988007 1356988014 1356989007 1463073002 1463073008 1463074006 1463075004 1463075010 1463076009 1463077006 1469330004 1469330012 1469330022 1472915006 1472915013 1472916004 1472916012 1472917003 1472917009 1472917016 1472917024 1472921006 1472921015 1472921027 1472922007 1472924004 1472927001 1472928001 1472928007 1472928014 1473420005 1473420013 1473420019 1473420026 1473690006 1473690013 1473690019 1473690025 1473692003 1473692010 1473692016 1473692022 1473996002 1473996010 1474001001 1474001009 1474001015 1474667010 1474668004 1474668011 1476187004 1476187013 1476188006 1476189004 1477298001 1481015007 1481015014 1484273007 1484273013 1484277006 1484277014 1484284008 1484285007 1484286007 1484291004 1484291013 1484293004 1484293013 1484293023 1484295002 1484295013 1484295025 1484320003 1484320018 1484320025 1484322009 1484323008 1484323014 1484323022 1484323028 1484324010 1484325005 1484325013 1484338013 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1581294006 1581296002 1581296012 1581549004 1581549012 1581647013 1585827004 1585831001 1586082002 1586090005 1586134004 1586286011 1586982004 1587881005 1587884001 1588001002 1588006012 1588493006 1588526011 1588687008 1588774008 1588778010 1590360010 1590360019 1590587005 1590751010 1590769009 1591097007 1591279002 1591279012 1591670010 1592089R015 1593048R018 1593107r015 1593387R011 1593407R016 1593517R016 1594191R011 1594391007 1594558001 1594558015 1594769014 1594925005 1595477001 1595477014 1595675005 1595725010 1596154009 1596421005 1596540008 1596669007 1598797011 1599020007 1601730003 1601733014 1602400009 1602401013 1604607010 1604740012 1607095004 |
Recalling Firm/ Manufacturer |
Endologix 35 Hammond Irvine CA 92618-1607
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Manufacturer Reason for Recall | Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular
AAA System (AFX System). |
FDA Determined Cause 2 | Device Design |
Action | Endologix sent a Dear Phycisicans Letter dated June 2, 2015, to all affected customers to inform them of the enclosed 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter informs the customers of the update reports the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
On January 2016, a Dear Physician letter was sent to inform the customers of the 2015 Clinical Update covering the Endologix Endovascular Systems
for AAA Repair. Customers were informed the update reports the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe
and effective use of these devices.
On 12/27/16, a Dear Physician letter was sent to inform customers of the important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers of a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented,
including introduction of a graft material processing improvement known as Duraply. The letter informs the customers that at the time of the submission of these modifications to FDA, they were not identified as measures intended to address Type III endoleaks. The on-going Endologix investigation has determined that these changes may help prevent the occurrence of Type III endoleaks reported with the AFX device. Customers with any questions are
instructed to contact their Endologix representative. |
Quantity in Commerce | 4,143 devices |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = MIH
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