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
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
How to identify it
UPC 0000616462 0000619851 0000552987 0000551725 00842429115893 0000552987 00842429115893 0000552987
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
Official source
Editorial summary by Recall Canary · last updated 2026-05-15 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification