LVIS Intraluminal Support Device Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,241 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.