Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems… — Class II medical device recall Z-1543-2017
Terminated recall by Medtronic Vascular, Inc., reported 2017-03-29, distributed in PR. Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurca
| Recall number | Z-1543-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2017-02-27 |
| Classified | 2017-03-23 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2018-03-01 |
| Distributed | PR |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LB, LK, LT, LU, LV, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UY, VE, VN, ZA |
| Quantity | 3,331 devices |
| UPC / GTIN / UDI-DI | 00006139949920, 00613994644251, 00613994644268, 00613994644282, 00613994644299, 00613994644312, 00613994644329, 00613994644336, 00613994644343, 00613994644350, 00613994644367, 00613994991164, 00613994991171, 00613994991188, 00613994991195, 00613994991201, 00613994991218, 00613994991225, 00613994991232, 00613994991249, 00613994991256, 00613994991263, 00613994991270, 00613994991935, 00613994991942 and 28 more |
| Serial numbers | 00613994644251, 00613994644268, 00613994644282, 00613994644299, 00613994644312, 00613994644329, 00613994644336, 00613994644343, 00613994644350, 00613994644367, 00613994991164, 00613994991171, 00613994991188, 00613994991201, 00613994991218, 00613994991232, 00613994991249, 00613994991263, 00613994991270, 00613994991935, 00613994991942, 00613994991959, 00613994991966, 00613994991973, 00613994991980 and 475 more |
| Model numbers | ETBF2313C124E, ETBF2313C145E, ETBF2313C166E, ETBF2316C124E, ETBF2316C145E, ETBF2316C166E, ETBF2513C124E, ETBF2513C145E, ETBF2513C166E, ETBF2516C124E, ETBF2516C145E, ETBF2516C166E |
Product
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Reason for recall
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
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-1543-2017. 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.