AFX Endovascular AAA System Item Number Item Description F0070305… — Class II medical device recall Z-1048-2017
Terminated recall by Endologix, reported 2017-01-25, distributed nationwide. Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and
| Recall number | Z-1048-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endologix, Irvine, CA, United States |
| Recall initiated | 2017-01-04 |
| Classified | 2017-01-19 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CL, DE, ES, FR, GR, IE, IL, IT, JP, MX, MY, PL, PT, RO, SE, SG, TH, TR |
| Quantity | 34 units |
| Serial numbers | 1047135, 1047135007, 1047170, 1047170016, 1055838, 1055838022, 1055838026, 1055877, 1055877010, 1056308, 1056308054, 1164318, 1164318019, 1164388, 1164388021, 1164389, 1164389009, 1164390, 1164390020, 1164470, 1164470015, 1164477, 1164477026, 1214252, 1214252011 and 37 more |
Product
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA F00555 I2020/C55F SA F00558 IS2025/C55 SA F00559 IS2025/C65 SA F0072605 A2525/C75O20 V F0072606 A2525/C95O20 V f00552 I1616/C88 SA F00557 I2013/C88F SA The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA
Reason for recall
Endologix updated information on the rates of Type III endoleaks and suggestions for patient surveillance and treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1048-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.