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U.S. Department of Health and Human Services

Class 2 Device Recall Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Cap

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 Class 2 Recall
Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Cap
see related information
Date Posted October 25, 2013
Recall Status1 Terminated on October 25, 2013
Recall Number Z-0083-2014
Recall Event ID 66322
Premarket Approval
PMA Numbers
P070007 P100040
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
Product Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
Code Information TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU.
Recalling Firm/
Manufacturer
Medtronic Vascular, Inc.
3850 Brickway Blvd
Santa Rosa, California 95403-8223
For Additional Information Contact Jonathan Morris
707-566-1143
Manufacturer Reason
for Recall
Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MIH and Applicant = MEDTRONIC INC.
PMAs with Product Code = MIH and Applicant = MEDTRONIC IRELAND
PMAs with Product Code = MIH and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = MIH and Applicant = MEDTRONIC VASCULAR GALWAY LIMITED
PMAs with Product Code = MIH and Applicant = MEDTRONIC VASCULAR INC
PMAs with Product Code = MIH and Applicant = MEDTRONIC, INC
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