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

FDA device recall Z-2200-2026 · posted 2026-05-14 · Open, Classified

Recall details

Recalling firm

MICROVENTION INC.

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

Action taken

On 4/6/2026, recall notices with TERUMO NEURO listed on notice top, were emailed to customers who were asked to do the following: 1) Stop using and quarantine affected devices. 2) Complete and return the acknowledgement form via email to -Distributors should provide the recall notice to medical facilities or users to whom you have distributed affected products. - Distributors should reconcile the completed forms from all customers and submit to recalling firm via email mvchinaqa@microvention.com If you have questions about this recall contact firm at max.huang@microvention.com

Root cause

Mixed-up of materials/components

Status

Open, Classified

Product code

QCA

Quantity affected

38

Distribution

International distribution to the country of China.

Date initiated

2026-04-06

Date posted

2026-05-14

Location

Aliso Viejo, CA