Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Valiant Navion Thoracic Stent Graft System. For endovascular repair of Recalled by Medtronic Vascular, Inc. Due to Due to the presence of type IIIb endoleaks,...

Date: February 12, 2021
Company: Medtronic Vascular, Inc.
Status: Ongoing
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 Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).

Quantity: 33,430 units

Why Was This Recalled?

Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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