Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Valiant Thoracic Stent Graft with Captivia Delivery System Recalled by Medtronic Vascular, Inc. Due to Firm received reports of difficulty in flushing the...

Date: September 19, 2012
Company: Medtronic Vascular, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular, Inc. directly.

Affected Products

Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.

Quantity: ~1000

Why Was This Recalled?

Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU.

Where Was This Sold?

International distribution:Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Iceland, Ireland, It lay, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom.

About Medtronic Vascular, Inc.

Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report