CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

Valiant Thoracic Stent Graft with Captivia Delivery System recalled

Medtronic Vascular is recalling Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft. The recall was initiated on 19 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Quantity recalled~1000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0083-2014
FDA event ID: 66322
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2012
FDA classified: 25 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Sep 2012	Recall initiated by company
25 Oct 2013	Classified by FDA	+401 days
6 Nov 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.

Product as listed by the FDA

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

Where it was distributed

International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.

Questions about this recall

Why was it recalled?

Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.

Which lots are affected?

TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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