Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR… — Class II medical device recall Z-1976-2021
Terminated recall by Medtronic Vascular, Inc., reported 2021-07-07, distributed nationwide. Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct ste
| Recall number | Z-1976-2021 |
|---|---|
| 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 | 2021-04-28 |
| Classified | 2021-06-28 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2024-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 3 devices |
| UPC / GTIN / UDI-DI | 00613994990983 |
| Serial numbers | V30064787, V30064789, V30064790 |
| Model numbers | ETBF3216C145E |
Product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Reason for recall
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
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-1976-2021. 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.