Z-0083-2014Class II

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

Name: Z-0083-2014 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia...
Creator: Medtronic Vascular, Inc.
Published: 2012-09-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-09-19 / Terminated / root cause: design

FDA source

Medtronic Vascular, Inc. began a recall of Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System on 2012-09-19. FDA classified it as Class II and gives the reason as "Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0083-2014
Classification: Class II
Status: Terminated
Initiated: 2012-09-19
Posted: 2013-10-25
Terminated: 2013-10-25
Recalling firm: Medtronic, Inc.
Product: Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
Root cause tag: design
FDA root cause: Component design/selection
Action: A Medical Device Information letter was sent to all affected customers on September 19, 2012. Additionally, all Medtronic Field Representatives were notified of the issue via a Field Memo
Quantity in commerce: ~1000
Distribution: 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.
Product codes and lots: TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0083-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0083-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-25

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)