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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 Device Recall Talent Thoracic Stent Graft Systemsee related information
Date Initiated by FirmFebruary 21, 2012
Date PostedMarch 23, 2012
Recall Status1 Terminated 3 on July 12, 2012
Recall NumberZ-1284-2012
Recall Event ID 61278
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
ProductTalent 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 CA 95403-1774
For Additional Information ContactChris 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		Process design
ActionMedtronic, 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 Commerce1523 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
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