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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 Device Recall Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Cap see related information
Date Initiated by Firm September 19, 2012
Date Posted October 25, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall Number Z-0083-2014
Recall Event ID 66322
PMA Number P100040/P070 
Product Classification Endovascular graft, aortic aneurysm treatment system - 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 CA 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MIH and Original Applicant = Medtronic Vascular
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