Reported Jan 25, 2017 · Terminated
AFX Endovascular AAA System, Endoleak Type IIIA
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 IIIA
- Lot codes and dates
- The correction is not lot specific. It applies to AFX procedures conducted after June 2013
- Amount recalled
- 40,967
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 initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and 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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