LVIS Intraluminal Support Device — Class II medical device recall Z-2200-2026
Ongoing recall by MICROVENTION INC., reported 2026-05-20. Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/
| Recall number | Z-2200-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2026-04-06 |
| Classified | 2026-05-14 |
| Reported by FDA | 2026-05-20 |
| Countries outside the US | CN |
| Quantity | 38 |
| UPC / GTIN / UDI-DI | 00842429115893, 00842429115930, 00842429115961 |
| Lot numbers | 0000551725, 0000552987, 0000616462, 0000619851 |
Product
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
Reason for recall
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
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-2200-2026. 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.