FDA Device recall Z-0083-2014
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System by Medtronic Vascular, citing firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0083-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-19 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Vascular |
| Distribution | n/a |
Product
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Reason
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Identifiers
| code_info | TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0083-2014%22
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