FDAFDA · Food and drugs·Recall number Z-1054-2017
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
Published January 25, 2017 · Recall initiated: December 27, 2016
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 the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Endologix
- Distributor
- US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
- Lot
- "AFX Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes 1046835-013 1054635-010 1251688004 1251688010 1251688016 1251688023 1251688030 1251689010 1251689021 1251689027 1251690005 1251690018 1251690024 1251692020 1251692027 1251740006 1251740013 1251740020 1251740026 1251740032 1251740038 1251740044 1251740050 1251740056 1251741003 1251741010 1251741016 1251741023 1251741029 1251742006 1251742014 1251742022 1251742032 1251742038 1251742045 1251742052 1251742058 1251743005 1251743012 1251743018 1251743027 1251744005 1251744012 1251745004 1251745010 1251745017 1251745026 1251747003 1251747026 1251748005 1251748016 1251748024 1251750003 1251750009 1251750027 1251751004 1251751012 1251751020 1251751029 1251751035 1251751043 1251751049 1251751057 1251752006 1251752012 1251752019 1251752025 1251753003 1251753010 1251753020 1251754003 1251754009 1251754015 1251754026 1251755004 1251755010 1251755016 1251755025 1251756003 1251756010 1251756020 1251757001 1251757009 1251758001 1251758010 1251758018 1251758026 1251775003 1251775010 1251775016 1251775022 1251775028 1251775034 1251775040 1251775046 1251775053 1251776002 1251776008 1251776014 1251776020 1251776026 1251777005 1251777011 1251777019 1251777026 1251778002 1251778008 1251778014 1251778020 1251778026 1251779006 1251779013 1251779020 1251779026 1251780002 1251780008 1251780014 1251780022 1251780028 1251781005 1251781015 1251781021 1251782009 1251784002 1251784009 1251784018 1251785001 1251785007 1251785015 1251785024 1251786003 1251786014 1251786020 1251786027 1251787002 1251787010 1251787016 1251787022 1251788006 1251788012 1251788019 1251788026 1251789008 1251789015 1251789021 1251789038 1251789045 1251789056 1251790009 1251790018 1251790026 1251791002 1251791008 1251791014 1251791020 1251791027 1251791034 1251791040 1251792006 1251792013 1251792019 1251792026 1251794021 1251795008 1251795017 1251795023 1251796002 1251796010 1251796019 1251796027 1251796034 1251796044 1251797006 1251797012 1251808005 1251808014 1251809005 1251809011 1251809019 1251809025 1251815003 1251815009 1251815016 1251815023 1251823005 1251823012 1251823020 1251823029 1251832005 1251832012 1251832018 1251832024 1251833001 1251833007 1251833013 1251834006 1251834012 1251834018 1251834024 1251836003 1251836012 1251837001 1251837009 1251837016 1251837023 1251837029 1251838007 1251850003 1251850009 1251850015 1251850023 1251850029 1251851006 1251851012 1251851018 1251851026 1251852002 1251852010 1251869002 1251869008 1251869014 1251870006 1251870012 1251870018 1251870025 1251871001 1251871008 1251871014 1251871021 1251871028 1251872005 1251872013 1251872019 1251872025 1251873004 1251873011 1251873017 1251873025 1251874001 1251874009 1251874017 1251874027 1251875006 1251875012 1251875019 1251875025 1251876002 1251876008 1251876014 1251876021 1251877002 1251877009 1251877016 1251877025 1251878011 1251878017 1251878025 1251879005 1251879012 1251879021 1251880002 1251880008 1251880014 1251880021 1251880027 1251880038 1251881007 1251881016 1251881023 1251882006 1251882014 1251882021 1251882027 1251888003 1251888010 1251889004 1251889011 1251890002 1251890008 1251890015 1251890021 1251890027 1251891003 1251891010 1251892001 1251892007 1251892015 1251892021 1251892027 1251893004 1251893010 1251894003 1251894010 1251900001 1251900007 1251900013 1251900019 1251900025 1251901001 1251901007 1251901013 1251901019 1251901025 1251902002 1251902008 1251902016 1251902022 1251902028 1251902034 1251902040 1251903001 1251903007 1251903014 1251903021 1251903027 1251904003 1251904009 1251904015 1251905006 1251905012 1251906003 1251906009 1251906015 1251906021 1251907001 1251907008 1251907014 1251907020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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