Reported Jan 25, 2017 · Terminated
AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03…
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?
22 of 22 products
| Model / number | Product as published |
|---|---|
BEA28-120/I20-40 | AFX2 Endovascular AAA System Item No. Item Description F00820-01 |
BEA28-100/I20-40 | F00820-02 |
BEA28-80/I20-40 | F00820-03 |
BEA28-120/I16-40 | F00820-06 |
BEA28-100/I16-40 | F00820-07 |
BEA28-80/I16-40 | F00820-08 |
BEA28-60/I16-40 | F00820-09 |
BEA28-110/I20-30 | F00820-16 |
BEA28-90/I20-30 | F00820-17 |
BEA28-70/I20-30 | F00820-18 |
BEA28-110/I16-30 | F00820-20 |
BEA28-90/I16-30 | F00820-21 |
BEA28-70/I16-30 | F00820-22 |
BEA25-120/I20-40 | F00820-28 |
BEA25-100/I20-40 | F00820-29 |
BEA25-80/I20-40 | F00820-30 |
BEA25-110/I20-30 | F00820-43 |
BEA25-90/I20-30 | F00820-44 |
BEA25-70/I20-30 | F00820-45 |
BEA22-80/I20-40 | F00820-57 |
- Lot codes and dates
1,664 of 1,664 codes
15941921594192R013159056515905650141590565159056500815201151520115008135473913547390191354736135473600215941921594192R01415941921594192R01015941921594192R00915986971598697008159869715986970031598697159869700115941921594192R01215941921594192R00615905651590565009159056515905650041590565159056500215173291517329008151732915173290061517329151732900515166411516641008151664115166410061472927147292700613547451354745011135474513547450091354740135474000813547401354740002135473913547390211354739135473901713547391354739014
- Amount recalled
- 832 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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