MicroVention LVIS Stent Device Recall
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-CA
Updated April 6, 2026
MicroVention's LVIS Intraluminal Support Device (stent) may have incorrect dimensions or configuration due to a manufacturing issue. If the stent is the wrong size, it can cause serious complications including vessel injury, blood clots, or stroke.
Is the MICROVENTION INC. recalled? Yes. This product was recalled by FDA on April 6, 2026. Details below.
What is recalled
LVIS Intraluminal Support Device with the following REF numbers: 214022-CAS (4.0 mm OD x 22 mm total length x 18 mm working length), 214518-CAS (4.5 mm OD x 18 mm total length x 14 mm working length), and 213517-CAS (3.5 mm OD x 17 mm total length x 13 mm working length).
Am I affected
You're affected if you have received the LVIS Intraluminal Support Device and the REF number on your device matches: 214022-CAS, 214518-CAS, or 213517-CAS. Check the device packaging or medical record for the REF number and dimensions listed.
What to do right now
Contact your physician or the healthcare facility where the device was implanted immediately. Do not attempt to remove the device yourself. Your doctor will determine if your specific device is affected and what follow-up care you may need.
The hazard
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
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2200-2026
- Classification
- Class II
- Recalled
- April 6, 2026
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