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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

LVIS Intraluminal Support Devices Recalled for Stent Deployment Failure

Agency Publication Date: February 7, 2025
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Summary

MicroVention Inc. has recalled 11 units of its LVIS Intraluminal Support Device, a medical stent used during brain aneurysm treatments. The recall was issued because the material covering the stent may prevent it from being pushed out of its delivery tube during surgery. No injuries have been reported, but a failure to deploy the stent correctly could lead to surgical complications or delays. If you or a family member have recently undergone an aneurysm procedure involving a stent, contact your healthcare provider or surgeon.

Risk

The material encasing the stent loop can stick to the delivery tube, preventing the stent from deploying into the patient's blood vessel. This defect could lead to an unsuccessful procedure or require additional medical intervention.

What You Should Do

  1. This recall affects the MicoVention Terumo LVIS Intraluminal Support Device, model REF: 213522-CAS, with lot number 0000456768.
  2. Stop using the recalled device immediately.
  3. Contact MicroVention Inc. or your distributor to arrange for the return, replacement, or correction of any unused units.
  4. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MicoVention Terumo, LVIS Intraluminal Support Device (3.5 mm x 22 mm)
Variants: od 3.5 mm, TL 22 mm, WL 18 mm, Sterile R
Model / REF:
213522-CAS
Lot Numbers:
0000456768

Intended to serve as a stent-assisted coiling (SAC) device for wide-necked aneurysms.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96114
Status: Active
Manufacturer: MICROVENTION INC.
Sold By: MicroVention Inc.
Manufactured In: United States
Units Affected: 11 units

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.