RecallRadar

FDA Device recall Z-0083-2014

Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System

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

AgencyFDA Device
Recall numberZ-0083-2014
ClassificationClass II
Statusterminated
Initiated2012-09-19
Published2013-11-06
Last updated2026-09-13 11:53 UTC
CompanyMedtronic Vascular
Distributionn/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_infoTBXXXXXXXXCP, 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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