Use caution Medical device recall · FDA · Published April 6, 2026

Microvention LVIS Stent Device Recall: Risk of Vessel Injury from Manufacturing Errors

Microvention recalls specific LVIS Intraluminal Support Devices due to potential manufacturing errors that could cause vessel injury, rupture, or neurological issues. Affected units include certain sizes and production lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2200-2026Medical device Microvention ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmMICROVENTION INC.35 Enterprise · Aliso Viejo, CA 92656

✎ GovInfoNow plain-language explainer

Microvention is recalling specific LVIS Intraluminal Support Devices that may have manufacturing errors causing them to be too large or too small. This could lead to vessel injury, rupture, or neurological complications if used improperly. Read more at govinfonow.com/recall/49539-microvention-lvis-stent-device-recall-risk-of-vessel-injury-from.

Source Summary by GovInfoNow · govinfonow.com/recall/49539-microvention-lvis-stent-device-recall-risk-of-vessel-injury-from · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2200-2026

Cite this page

“Microvention LVIS Stent Device Recall: Risk of Vessel Injury from Manufacturing Errors.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49539-microvention-lvis-stent-device-recall-risk-of-vessel-injury-from. Based on FDA recall #Z-2200-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2026%22&limit=1).

The FDA announced on April 6, 2026, that Microvention Inc. is recalling LVIS Intraluminal Support Devices due to potential dimensional nonconformance and incorrect device configuration caused by manufacturing commingling. The agency issued recall number Z-2200-2026 for the Class II voluntary recall affecting products distributed internationally to China.

How to tell if you have it

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22
UPC 00842429115893
UPC 00842429115930
UPC 00842429115961
Lot codes: 0000616462, 0000619851, 0000552987, 0000551725

The hazard

The stent-assisted coiling device may have dimensional nonconformance and/or incorrect device configuration due to commingling during manufacturing. If oversized, the device may lead to increased vessel wall stress, neointimal hyperplasia, or vessel injury/rupture; if undersized, it may cause incomplete expansion/malposition, acute stent thrombosis, distal embolization, or ischemic neurological events.

Context

GovInfoNow's records show Microvention Inc. has 15 other recalls on record since 2017-08-07. Recent brand recalls include a Bobby Balloon Guide Catheter recall for balloon pinhole defects on 2026-04-30, Flow Re-Direction Devices with incomplete deployment risks on 2025-09-05, and LIFEPEARL Drug Elutable Microspheres with ineffective treatment risks on 2025-05-29. Other recent recalls of similar products include the Micro Therapeutics Pipeline Flex Embolization Device for incorrect labeling risk on 2026-06-08, the INSPIREMD CGuard Prime Carotid Stent System for deployment complications risk on 2026-05-01, and the Bard Ureteral Stent Kit for label size mismatch risk on 2025-11-06.

How to tell if you have this one

Check the device's model code: 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, or 213517-CAS/3.5 mm x 17 mm x 13 mm. Also look for production lots 0000552987, 0000551725, 0000616462, or 0000619851.

Brand
Microvention
Product
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify the device model code and production lot number against the list provided in the recall notice.
Contact Manufacturer
Reach out to Microvention directly for further assistance or to confirm if your device is affected.

How this recall unfolded

Recall timeline

FDA published this recall 44 days after the firm started it.

Apr 6, 2026Firm started the recall
May 14, 2026FDA classified it Class II
May 20, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49539-microvention-lvis-stent-device-recall-risk-of-vessel-injury-from">Microvention LVIS Stent Device Recall: Risk of Vessel Injury from Manufacturing Errors (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2200-2026 (April 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2200-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.