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.
Recall
- Recall Number
- Z-1284-2012
- Event Number
- 61278
- Firm
- Medtronic Vascular, Inc.
- FEI Number
- 3001452571
- Product Code
- MIH
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- February 21, 2012
- Posted
- March 23, 2012
- Terminated
- July 12, 2012
- Address
- 3576 Unocal Pl, Santa Rosa, CA, 95403-1774
Description
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.
Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.
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.
Nationwide Distribution
1523 units