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 Type IIIB Common NameAFX Bifurcated and Accessory
- Stent Grafts Classification NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
- Lot codes and dates
- "AFX Duraply Lot Codes (July 2015 - Nov. 2016)" Lot CodesLot Codes
2,360 of 2,360 codes
1046835-0131054635-0101251688004125168801012516880161251688023125168803012516890101251689021125168902712516900051251690018125169002412516920201251692027125174000612517400131251740020125174002612517400321251740038125174004412517400501251740056125174100312517410101251741016125174102312517410291251742006125174201412517420221251742032125174203812517420451251742052125174205812517430051251743012125174301812517430271251744005125174401212517450041251745010125174501712517450261251747003125174702612517480051251748016125174802412517500031251750009125175002712517510041251751012125175102012517510291251751035
1350 of 350 codes
1053145-0021055815-0141251688005125168801112516880181251688024125168900112516890111251689022125168902812516900071251690019125169002512516920211251692029125174000712517400141251740021125174002712517400331251740039125174004512517400511251740057125174100512517410111251741017125174102412517420011251742007125174201612517420231251742033125174203912517420471251742053125174205912517430071251743013125174301912517430281251744006125174401312517450051251745011125174501812517450271251747005125174702812517480071251748018125174902712517500041251750014125175002912517510051251751014125175102112517510301251751037
- "AFX Duraply Lot Codes (July 2015 - Nov. 2016)" Lot Codes
- Amount recalled
- 17,139 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
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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