AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts…
Medical device recall Z-1039-2017. Published in FDA’s Enforcement Report on Jan 25, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 25, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4,143 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Endologix updated the Instructions for Use (IFU) and implemented modifications to the AFX Endovascular AAA System (AFX System).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
4,143 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
“AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)” Lot Codes 1298056012 1354736007 1354737005 1354738002 1354739002 1354739008 1354739020 1354739027 1354740011 1354745005 1354798002 1354798008 1354798014 1354799004 1354800001 1354800008…
Every code shown here, 1,995 characters
“AFX2 Duraply Lot Codes (July 2015 - Nov. 2016)” Lot Codes 1298056012 1354736007 1354737005 1354738002 1354739002 1354739008 1354739020 1354739027 1354740011 1354745005 1354798002 1354798008 1354798014 1354799004 1354800001 1354800008 1354800014 1354801006 1354801013 1354802004 1354802010 1354804006 1354806001 1354806007 1354806019 1354806026 1354807003 1354807009 1354808003 1354808009 1354809009 1354809015 1354810008 1354810015 1354810022 1354859002 1354859009 1354859016 1354859025 1354860005 1354861001 1354861008 1354861014 1354861021 1354861027 1354862004 1354862011 1354862017 1354862027 1354863007 1354865009 1354865017 1354865025 1354867004 1354867012 1354867020 1354867028 1354921006 1354922002 1354922010 1354922018 1354922024 1354923002 1354923009 1354923015 1354923021 1354924003 1354924012 1354924018 1354924026 1354925005 1354925012 1354925018 1354925024 1354926005 1354926013 1354926020 1354926026 1354927006 1354927019 1354927029 1354928007 1354929005 1354929011 1354980004 1354981001 1354981008 1354982003 1354982010 1354983015 1355041003 1355041011 1355041020 1355042001 1355042008 1355042015 1355042021 1355042027 1355043010 1355044004 1355044013 1355044023 1355047007 1355102002 1355102008 1355102014 1355103009 1355103015 1355103021 1355103029 1355104006 1355104016 1355104024 1355105007 1355106001 1355106007 1355106013 1355162005 1355163005 1355163011 1355164007 1355165006 1355165019 1355224004 1355224011 1355224018 1355224027 1355225006 1355225018 1355285001 1355285008 1355344002 1355344010 1355345007 1355345013 1355346005 1355346011 1355347004 1355347010 1355404009 1355404017 1355404024 1355405005 1355405019 1355405028 1355407005 1355407015 1355407023 1355467003 1355467010 1355468002 1355468009 1355469006 1355469014 1355469021 1355470002 1355470009 1355470016 1355470024 1355471002 1355471009 1355472003 1355472012 1355472021 1355473001 1355473008 1355473015 1355473026 1355474007 1355475003 1355475012 1355526005 1355527004 1355528003 1355528011 1355528021…
FDA’s list runs to 45,670 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 27, 2016.
- FDA classified it on Jan 19, 2017.
- FDA’s Enforcement Report published it on Jan 25, 2017.
- FDA terminated it on Apr 28, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Endologix, of Irvine, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 45,670 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.