Reported Oct 10, 2018 · Terminated
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55,…
Endologix
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
ENDOLOGIX AFX/AFX2Limb (Iliac) Extension EndograftRx OnlySterile EOAFX Limb Accessory Model #/REF: I16-16/C55I16-16/C55FI16-16/C88I20-13/C70FI20-13/C88FI16-16/C55I16-16/C55FI16-16/C88I20-13/C70FI20-13/C88FAFX Stand Alone I16-16/C55 SAI16-16/C55F SAI16-16/C88 SAI20-13/C70F SAI20-13/C88F SAI20-20/C55 SAI20-20/C55F SAIS20-25/C55 SAIF20-25/C65 SAIS20-25/C65 SA
- Lot codes and dates
- All lots distributed from 03/2011 to present.
- Amount recalled
- 17789
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.
Using this product could cause serious injury, illness or death — stop using it now.
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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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