Valiant Navion Thoracic Stent Graft System — Class I medical device recall Z-1201-2021
Ongoing recall by Medtronic Vascular, Inc., reported 2021-03-17, distributed nationwide. Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
| Recall number | Z-1201-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2021-02-12 |
| Classified | 2021-03-10 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, DE, DK, ES, FI, FR, GB, GR, HK, HN, HR, HU, IE, IL, IN, IT, JP, KR, KW, LU, MT, MY, NL, NO, NZ, PE, PH, PL, PT, QA, RS, SA, SE, SG, SI, SK, SV, TH, TT, TW, UA, UY, VN, ZA |
| Quantity | 33,430 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00763000100520, 00763000100537, 00763000100544, 00763000100551, 00763000100568, 00763000100575, 00763000100582, 00763000100599, 00763000100605, 00763000100612, 00763000100629, 00763000100636, 00763000100643, 00763000100650, 00763000100667, 00763000100674, 00763000100681, 00763000100698, 00763000100704, 00763000100711, 00763000100728, 00763000100735, 00763000100742, 00763000100759, 00763000100766 and 351 more |
| Serial numbers | 30047845, 334, 3506, 562095, 80019, 9933558, V07881229, V07881230, V07881231, V07881232, V07881233, V07881234, V07881235, V07881237, V07881238, V07881239, V07881241, V07881244, V07881245, V07881246, V07881247, V07881248, V07881249, V07881250, V07881252 and 475 more |
| Model numbers | VNMC2020C94TE, VNMC2020C94TJ, VNMC2020C94TU, VNMC2222C180TE, VNMC2222C180TJ, VNMC2222C180TU, VNMC2222C94TE, VNMC2222C94TJ, VNMC2222C94TU, VNMC2520C186TE, VNMC2520C186TJ, VNMC2520C186TU, VNMC2525C180TE, VNMC2525C180TJ, VNMC2525C180TU, VNMC2525C94TE, VNMC2525C94TJ, VNMC2525C94TU, VNMC2822C207TE, VNMC2822C207TJ, VNMC2822C207TU, VNMC2828C182TE, VNMC2828C182TJ, VNMC2828C182TU, VNMC2828C90TE and 201 more |
Product
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Reason for recall
Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
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-1201-2021. 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.