Reported Jan 25, 2017 · Terminated
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V…
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?
12 of 12 products
| Model / number | Product as published |
|---|---|
A2525/C75 | Description F0070305 |
A2828/C75 | V F0070308 |
A3434/C80 | V F0070312 |
I1616/C55F | V f00553 |
I2013/C70F | SA F00556 |
I2020/C55F | SA F00555 |
IS2025/C55 | SA F00558 |
IS2025/C65 | SA F00559 |
A2525/C75O20 | SA F0072605 |
A2525/C95O20 | V F0072606 |
I1616/C88 | V f00552 |
I2013/C88F | SA F00557 |
- Lot codes and dates
- Lot # Lot/Serial
68 of 68 codes
116431811643180191164390116439002011643891164389009116438811643880211262039126203900212465961246596024116447711644770261164470116447001510558381055838026105583810558380221250434125043400212497431249743025125705812570580171055877105587701012493631249363009124935812493580251267536126753600810471701047170016126753612675360251257553125755302012142521214252011122934612293460071274322127432200312579771257977011125042412504240161250424125042400812504241250424007125039912503990241047135104713500712751671275167014
- Lot # Lot/Serial
- Amount recalled
- 34 units
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
- FL
Why it was recalled
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
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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