# FDA recall Z-0464-2022

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2021-11-19.

## Product

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

## Reason for recall

There have been reports of stent migration.

## Distribution

Distribution was nationwide.  There was also military/government distribution.  Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

## Key facts

- **Recall number:** Z-0464-2022
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-19
- **Report date:** 2022-01-12
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0464-2022

## Citation

> AI Analytics. FDA recall Z-0464-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0464-2022. Source: US FDA. Licensed CC0.

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