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Terminated

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.

FDA Recall Z-1284-2012 · Posted 2012-03-23

Recalling FirmMedtronic Vascular, Inc.
Recall StatusTerminated
Product CodeMIH
Date Initiated2012-02-21
Date Terminated2012-07-12
Product Quantity1523 units

Reason for Recall

Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.

Firm 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.

Root Cause

Process design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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