LVIS Intraluminal Support Device
MicroVention recalls LVIS Intraluminal Support Devices (REF 214022-CAS, 214518-CAS, 213517-CAS) due to dimensional nonconformance risking vessel injury or thrombosis.
If you have received this device, contact MicroVention immediately to verify whether your device is affected and to discuss appropriate next steps, which may include device replacement or retrieval.
Why it was recalled
MicroVention is recalling LVIS Intraluminal Support Devices (REF 214022-CAS, 214518-CAS, 213517-CAS) due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling. Oversized devices may cause increased vessel wall stress, neointimal hyperplasia, or vessel injury/rupture; undersized devices may lead to incomplete expansion, malposition, acute stent thrombosis, distal embolization, or ischemic neurological events.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
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
- Lot code
- 0000616462, 0000619851, 0000552987, 0000551725
- UDI-DI
- 0000616462, 0000619851, 0000552987, 0000551725, 00842429115893, 0000552987, 00842429115893, 0000552987, 00842429115893, 0000552987, 00842429115930, 0000551725, 00842429115930, 0000551725, 00842429115930, 0000616462, 00842429115930, 0000616462, 00842429115961, 0000619851
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from MICROVENTION INC.
Editorial summary by Recall Canary · summary updated 2026-05-15 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification