Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
- Company
- Medtronic Vascular, Inc.
- Recall Initiated
- September 19, 2012
- Posted
- October 25, 2013
- Terminated
- October 25, 2013
- Recall Number
- Z-0083-2014
- Quantity
- ~1000
- Firm Location
- Santa Rosa, CA
Reason for Recall
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
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 / Code Info
TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
Root Cause
Component design/selection
Action Taken
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