# FDA recall Z-1201-2021

> **Medtronic Vascular, Inc.** · Class I · device recall initiated 2021-02-12.

## Product

Valiant Navion Thoracic Stent Graft System.  For endovascular repair of lesions in the descending thoracic aorta (DTA).

## Reason for recall

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

## Distribution

Worldwide distribution.  US Nationwide, Italy, Denmark, Germany, Finland, Chile, Russian Federation, Norway, South Africa, New Zealand, Australia, United Kingdom, Switzerland, Austria, Netherlands, Spain, Portugal, France, Israel, Greece, Thailand, Ireland, Colombia, Canada, Hong Kong, Sweden, Belgium, Saudi Arabia, Malaysia, Singapore, Brazil, Macau, Luxembourg, Viet Nam, Taiwan, Croatia, Serbia, United Arab Emirates, Slovenia, Philippines, Poland, Japan, Costa Rica, Hungary, Korea, Slovakia, Malta, Bahrain, Kuwait, Qatar, Reunion, Honduras, Mauritius, India, Peru, El Salvador, Ukraine, Uruguay, Trinidad and Tobago.

## Key facts

- **Recall number:** Z-1201-2021
- **Recalling firm:** Medtronic Vascular, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-02-12
- **Report date:** 2021-03-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Rosa, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2021

## Citation

> AI Analytics. FDA recall Z-1201-2021. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1201-2021. Source: US FDA. Licensed CC0.

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