FDA Medical Device Recalls (openFDA)
Medtronic Vascular, Inc.: Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
- Recall number
- Z-0083-2014
- Recalling firm
- Medtronic Vascular, Inc.
- Product
- Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
- Status
- Terminated
- Initiated
- 2012-09-19
- Posted
- 2013-10-25
- Terminated
- 2013-10-25
- Reason
- Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
- 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
- ~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.
- Lot, serial or model codes
- TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
- 510(k) numbers
- not on file
- PMA numbers
- ["P100040/P070"]
- Product code
- MIH
- Firm FEI
- 3005364322
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28