MICROVENTION INC. — Class II recall: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWork…

Summary

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 expans… Status: Ongoing.

Entities

• MICROVENTION INC.