MICROVENTION INC. recalls LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22…

Recall date

April 6, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2200-2026

FDA classification

Class II

Brand / firm

MICROVENTION INC.

Sold / distributed

International distribution to the country of China.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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