Recall Z-2200-2026 ยท QCA Intracranial Coil-Assist Stent
MICROVENTION INC.
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
| Date | May 14, 2026 (initiated Apr 6, 2026) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 38 |
| Distribution | International distribution to the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.