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Unrated Medical device recall · FDA · Published December 11, 2024

MicoVention Terumo LVIS Intraluminal Support Device Recall: Stent May Not Push Out

MicoVention Terumo recalls specific LVIS Intraluminal Support Devices due to risk of stent not being pushed out of the introducer during use, potentially causing complications.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1121-2025Medical deviceMicoVention Terumo ›
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Contact the company

Recalling firmMICROVENTION INC.35 Enterprise · Aliso Viejo, CA 92656
✎ GovInfoNow plain-language explainer

MicoVention Terumo is recalling a specific type of stent device for treating aneurysms. The device may not push out of the introducer catheter during use, which could lead to complications if the stent gets stuck. Read more at govinfonow.com/recall/53316-micovention-terumo-lvis-intraluminal-support-device-recall-stent-may-not.

Source Summary by GovInfoNow · govinfonow.com/recall/53316-micovention-terumo-lvis-intraluminal-support-device-recall-stent-may-not · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1121-2025

Cite this page

“MicoVention Terumo LVIS Intraluminal Support Device Recall: Stent May Not Push Out.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53316-micovention-terumo-lvis-intraluminal-support-device-recall-stent-may-not. Based on FDA recall #Z-1121-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2025%22&limit=1).

The FDA announced on Dec. 11, 2024, that MICROVENTION INC. is recalling MicoVention Terumo LVIS Intraluminal Support Devices due to a potential for the PTFE material encasing the stent loop to prevent the stent from being pushed out of the introducer.

How to tell if you have it

  • Brand: MicoVention Terumo
  • Product: LVIS Intraluminal Support Device
  • REF: 213522-CAS
  • Size: od, 3.5 mm, TL 22 mm, WL 18 mm
  • Lot number: 0000456768

The hazard

The hazard is the potential for Polytetrafluoethylene (PTFE) material encasing the stent loop to prevent the stent from being pushed out of the introducer, according to the FDA.

Context

GovInfoNow's records show MICROVENTION INC. has 15 other recalls on record since 2017-08-07. Other recent recalls of similar products include Merit Medical Allwell Angioplasty Pack Recall (2025-12-04), Soft-Vu Angiographic Catheter Recall (2026-03-03) and INSPIREMD CGuard Prime Carotid Stent System Recall (2026-05-01).

How to tell if you have this one

Check for the model REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm on the device. The device is sterile and labeled with CE0297.

  • Brand
    MicoVention Terumo
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Look for the model REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm on the device.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 11, 202412. FDA classified it Class II: Feb 7, 202523. Published in FDA’s Enforcement Report: Feb 19, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1121-2025 (December 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1121-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA