AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts…
Medical device recall Z-1054-2017. 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
- Not named no state, in where it went
- 17,139 units 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
17,139 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
“AFX Duraply Lot Codes (July 2015 - Nov. 2016)” Lot Codes 1046835-013 1054635-010 1251688004 1251688010 1251688016 1251688023 1251688030 1251689010 1251689021 1251689027 1251690005 1251690018 1251690024 1251692020 1251692027 1251740006…
Every code shown here, 1,996 characters
“AFX Duraply Lot Codes (July 2015 - Nov. 2016)” Lot Codes 1046835-013 1054635-010 1251688004 1251688010 1251688016 1251688023 1251688030 1251689010 1251689021 1251689027 1251690005 1251690018 1251690024 1251692020 1251692027 1251740006 1251740013 1251740020 1251740026 1251740032 1251740038 1251740044 1251740050 1251740056 1251741003 1251741010 1251741016 1251741023 1251741029 1251742006 1251742014 1251742022 1251742032 1251742038 1251742045 1251742052 1251742058 1251743005 1251743012 1251743018 1251743027 1251744005 1251744012 1251745004 1251745010 1251745017 1251745026 1251747003 1251747026 1251748005 1251748016 1251748024 1251750003 1251750009 1251750027 1251751004 1251751012 1251751020 1251751029 1251751035 1251751043 1251751049 1251751057 1251752006 1251752012 1251752019 1251752025 1251753003 1251753010 1251753020 1251754003 1251754009 1251754015 1251754026 1251755004 1251755010 1251755016 1251755025 1251756003 1251756010 1251756020 1251757001 1251757009 1251758001 1251758010 1251758018 1251758026 1251775003 1251775010 1251775016 1251775022 1251775028 1251775034 1251775040 1251775046 1251775053 1251776002 1251776008 1251776014 1251776020 1251776026 1251777005 1251777011 1251777019 1251777026 1251778002 1251778008 1251778014 1251778020 1251778026 1251779006 1251779013 1251779020 1251779026 1251780002 1251780008 1251780014 1251780022 1251780028 1251781005 1251781015 1251781021 1251782009 1251784002 1251784009 1251784018 1251785001 1251785007 1251785015 1251785024 1251786003 1251786014 1251786020 1251786027 1251787002 1251787010 1251787016 1251787022 1251788006 1251788012 1251788019 1251788026 1251789008 1251789015 1251789021 1251789038 1251789045 1251789056 1251790009 1251790018 1251790026 1251791002 1251791008 1251791014 1251791020 1251791027 1251791034 1251791040 1251792006 1251792013 1251792019 1251792026 1251794021 1251795008 1251795017 1251795023 1251796002 1251796010 1251796019 1251796027 1251796034 1251796044 1251797006 1251797012 1251808005 1251808014…
FDA’s list runs to 167,342 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.
US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 167,342 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
-
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.