Valiant Thoracic Stent Graft with Captivia Delivery System — Class II medical device recall Z-0083-2014
Terminated recall by Medtronic Vascular, Inc., reported 2013-11-06. Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparati
| Recall number | Z-0083-2014 |
|---|---|
| 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 | 2012-09-19 |
| Classified | 2013-10-25 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2013-10-25 |
| Countries outside the US | AT, BE, CH, CY, CZ, DE, DK, ES, FI, GB, GR, HU, IE, IS, LT, LU, LV, NL, NO, PL, PT, SE, SI, SK, TR |
| Quantity | 1,000 |
Product
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Reason for recall
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
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-0083-2014. 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.