Reported Jan 25, 2017 · Terminated
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification…
Endologix
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Endologix · 35 Hammond · Irvine, CA · 92618-1607
Is this the product you have?
- AFX Endovascular AAA System
- Endoleak TypeIIIB
- Common NameAFX Bifurcated and Accessory
- Stent Grafts Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA)
- Lot codes and dates
- "AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)" Lot CodesLot Codes
690 of 690 codes
129805601213547360071354737005135473800213547390021354739008135473902013547390271354740011135474500513547980021354798008135479801413547990041354800001135480000813548000141354801006135480101313548020041354802010135480400613548060011354806007135480601913548060261354807003135480700913548080031354808009135480900913548090151354810008135481001513548100221354859002135485900913548590161354859025135486000513548610011354861008135486101413548610211354861027135486200413548620111354862017135486202713548630071354865009135486501713548650251354867004135486701213548670201354867028135492100613549220021354922010
Lot Codes690 of 690 codes
135473600113547360081354737006135473800313547390031354739009135473902213547400011354740012135474500613547980031354798009135479801513547990051354800002135480000913548010011354801007135480101413548020051354803001135480400913548060021354806008135480602013548060271354807004135480701013548080041354809001135480901013548100021354810009135481001613548100231354859003135485901013548590181354859026135486000613548610021354861009135486101513548610221354861029135486200513548620121354862019135486202913548630081354865010135486501813548650261354867005135486701313548670211354867029135492100713549220031354922011
Lot Codes690 of 690 codes
135473600313547370011354737007135473800413547390041354739012135473902313547400031354745001135474500813547980041354798010135479801613547990061354800003135480001013548010021354801009135480101513548020061354803002135480401013548060031354806009135480602113548060281354807005135480701113548080051354809002135480901113548100031354810010135481001713548100241354859005135485901113548590191354860001135486000713548610031354861010135486101613548610231354861030135486200613548620131354862021135486300213548630101354865013135486501913548650281354867006135486701413548670221354867030135492100813549220041354922012
637 of 637 codes
135473600413547370021354737008135473800513547390051354739013135473902413547400051354745002135474501013547980051354798011135479900113547990071354800004135480001113548010031354801010135480200113548020071354803003135480401213548060041354806010135480602313548060291354807006135480701313548080061354809003135480901213548100041354810011135481001813548100251354859006135485901213548590221354860002135486000813548610041354861011135486101713548610241354862001135486200713548620141354862022135486300313548630111354865014135486502013548650291354867008135486701513548670241354921001135492100913549220071354922013
- "AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes
- Amount recalled
- 4,143 devices
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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