# FDA recall Z-1098-2026

> **Medtronic Inc** · Class II · device recall initiated 2025-12-04.

## Product

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090  AB9G12100090  AB9G14080090  AB9G12080090  AB9U12060090  AB9U14100090  AB9U14080090  AB9U12080090  AB9U14060090  AB9G14100090  AB9G12060090

## Reason for recall

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

## Distribution

Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan,  Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain,  Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.

## Key facts

- **Recall number:** Z-1098-2026
- **Recalling firm:** Medtronic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-04
- **Report date:** 2026-01-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2026

## Citation

> AI Analytics. FDA recall Z-1098-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1098-2026. Source: US FDA. Licensed CC0.

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