Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs… — Class II medical device recall Z-2136-2021
Ongoing recall by Medtronic Vascular, Inc., reported 2021-08-04, distributed in GA, MA, MD, NY, SC, TX, WA, WV. During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (
| Recall number | Z-2136-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2021-06-07 |
| Classified | 2021-07-23 |
| Reported by FDA | 2021-08-04 |
| Distributed | GA, MA, MD, NY, SC, TX, WA, WV |
| Countries outside the US | AR, AU, CH, DE, ES, GB, GR, IL, IT, NL, PL, ZA |
| Quantity | 21 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00643169439962, 00643169780460 |
| Serial numbers | V29780759, V29780771, V29780773, V29781932, V29781933, V29781934, V29781935, V29781936, V29781937, V29781938, V29781939, V29781940, V29781941, V29781942, V29781943, V29781944, V29781945, V29781946, V29781947, V29781948, V29781951 |
| Model numbers | ESBF3214C103E, ESBF3614C103EE |
Product
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
Reason for recall
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
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-2136-2021. 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.