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U.S. Department of Health and Human Services

Class 2 Device Recall Talent Thoracic Stent Graft System

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 Class 2 Recall
Talent Thoracic Stent Graft System
see related information
Date Posted March 23, 2012
Recall Status1 Terminated on July 12, 2012
Recall Number Z-1284-2012
Recall Event ID 61278
Premarket Approval
PMA Number
P070007/S021
Product Classification System, Endovascular Graft, Aortic Aneurysm Treatment - Product Code MIH
Product Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation: TFXXXXXXXXCP and TBXXXXXXXXCP. Medtronic Inc. Santa Rosa, CA 95403. The Talent® Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion, the stent graft provides an alternative conduit for blood flow within a patients vasculature by excluding the lesion from blood flow and pressure.
Code Information TB2222C116CP, TF2424C116CP, TF2626C116CP, TF2828C116CP, TF3030C115CP, TF3232C115CP, TF3434C115CP, TF3636C114CP, TF3838C114CP, TF4040C114CP, TF4242C113CP, TF4444C113CP, TF4646C112CP, TB2222C161CP, TF2424C161CP, TF2626C161CP, TF2828C161CP, TF3030C160CP, TF3232C160CP, TF3434C160CP, TF3636C159CP; TF3838C159CP, TF4040C159CP, TF4242C158CP, TF4444C158CP, TF4646C157CP, TB2222C201CP, TF2424C201CP, TF2626C201CP, TF2828C201CP, TF3030C200CP, TF3232C200CP, TF3434C200CP, TF3636C199CP, TF3838C199CP, TF4040C199CP, TF4242C198CP, TF4444C198CP, TF4646C197CP.
Recalling Firm/
Manufacturer
Medtronic Vascular, Inc.
3576 Unocal Pl
Santa Rosa, California 95403-1774
For Additional Information Contact Chris Hadland
707-566-1110
Manufacturer Reason
for Recall
Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.
FDA Determined
Cause 2
DESIGN: Process Design
Action Medtronic, Inc. sent an Urgent Medical Device Safety Information letter dated February 2012, to all affected customers. The letter identified the product, the problem, and the corrective action taken by Medtronic. Medtronic updated the Instructions for Use (IFU) manual. For questions regarding this recall call 707-566-1110.
Quantity in Commerce 1523 units
Distribution Nationwide Distribution
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.
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