Medtronic Vascular, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0083-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 19, 2012

Date Posted: November 6, 2013

Recall Number: Z-0083-2014

Event ID: 66322

Reason for Recall:

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

Status: Terminated

Product Quantity: ~1000

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated