Z-1284-2012

Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following...

Name: Z-1284-2012 Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following...
Creator: Medtronic Vascular, Inc.
Published: 2012-02-21
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-02-21 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular, Inc. began a recall of Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected have the following designation: TFXXXXXXXXCP and TBXXXXXXXXCP... on 2012-02-21. The reason FDA records is "Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1284-2012
Status: Terminated
Initiated: 2012-02-21
Posted: 2012-03-23
Terminated: 2012-07-12
Recalling firm: Medtronic, Inc.
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.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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.

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)