FDA Medical devices recall ·
MicoVention Terumo, LVIS Intraluminal Support Device recall
- Recall number
- Z-1121-2025
- Date
- (initiated December 11, 2024)
- Company / brand
- Microvention Inc.
35 Enterprise, Aliso Viejo, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number: 0000456768
Distribution
US: None OUS: China
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1121-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.