---
title: "MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... — FDA record Z-1121-2025 | Is It on Recall"
description: "Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer."
url: https://isitonrecall.com/recall/fda-device-z-1121-2025-micovention-terumo-lvis-intraluminal-support-device-ref-213522-cas-od-3-5-mm-tl-22-mm-wl-18-mm-steri/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0... — FDA record Z-1121-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- **Classification**: Class II
- **Recalling firm**: MICROVENTION INC.
- **Quantity**: 11 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1121-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1121-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot number: 0000456768 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: None OUS: China

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Feb 19, 2025
- **Recall initiation date**: Dec 11, 2024
- **Center classification date**: Feb 7, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1121-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [MICROVENTION INC. records](https://isitonrecall.com/brand/microvention-inc/)