# FDA recall Z-1121-2025

> **MICROVENTION INC.** · Class II · device recall initiated 2024-12-11.

## Product

MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297.  The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.

## Reason for recall

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

## Distribution

US: None OUS: China

## Key facts

- **Recall number:** Z-1121-2025
- **Recalling firm:** MICROVENTION INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-11
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2025

## Citation

> AI Analytics. FDA recall Z-1121-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1121-2025. Source: US FDA. Licensed CC0.

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