LVIS Intraluminal Support Device Recall

Source: FDA · China

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Microvention Inc. is recalling 38 LVIS Intraluminal Support Devices distributed to China due to potential dimensional nonconformance from manufacturing commingling.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 2, 2026 and geographically references China. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, devices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Microvention Inc. initiated a voluntary recall of certain LVIS Intraluminal Support Devices because the stent-assisted coiling device may have dimensional nonconformance and/or incorrect device configuration due to commingling during manufacturing.

Which Products Are Affected

The recall affects 38 units of the LVIS Intraluminal Support Device with the following REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL) specifications: 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, and 213517-CAS/3.5 mm x 17 mm x 13 mm. Affected lots are 0000616462, 0000619851, 0000552987, and 0000551725. The devices were distributed internationally to China. Recall number Z-2200-2026. Classification: Class II.

What You Should Do

Consumers and healthcare providers should follow any instructions provided by the recalling firm regarding the affected devices.

Why This Matters

If the device is oversized it may lead to increased vessel wall stress, neointimal hyperplasia, or vessel injury/rupture; if undersized it may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, or ischemic neurological events.

Source

FDA recall Z-2200-2026, report date 20260520.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Microvention Inc. is recalling 38 LVIS Intraluminal Support Devices distributed to China due to potential dimensional nonconformance from manufacturing commingling.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects China. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.