LVIS Intraluminal Support Device
The LVIS Intraluminal Support Device may have dimensional nonconformance or incorrect configuration, potentially causing vessel injury or incomplete expansion.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
MicroVention Inc., of Aliso Viejo, California, began a recall on April 6, 2026, of the LVIS Intraluminal Support Device due to possible commingling during manufacturing that may result in dimensional nonconformance and/or incorrect device configuration. The recall was added to the FDA's Enforcement Report on May 14, 2026, and the product was distributed internationally to China.
If the device is oversized, it may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury or rupture; if undersized, it may lead to incomplete expansion or malposition, acute stent thrombosis, distal embolization, and ischemic neurological events.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
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
- UDI-DI
- 0000616462
- 0000619851
- 0000552987
- 0000551725
- 00842429115893
- 00842429115930
- 00842429115961
Details
- Company began the recall
- Sold in
International distribution to the country of China.
- Event ID
- 98755
- Recall No.
- Z-2200-2026
- Company
- MICROVENTION INC.Aliso Viejo, California
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
