MicoVention Terumo — Class II medical device recall Z-1121-2025
Ongoing recall by MICROVENTION INC., reported 2025-02-19. Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being p
| Recall number | Z-1121-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2024-12-11 |
| Classified | 2025-02-07 |
| Reported by FDA | 2025-02-19 |
| Countries outside the US | CN |
| Quantity | 11 units |
| Lot numbers | 0000456768 |
| Model numbers | 213522-CAS, 3.5 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1121-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.