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FDA-Device2026-05-20Class IIPROCESSING DEFECT

MicroVention LVIS Intraluminal Support Device recalled for dimensional nonconformance

Microvention
OTHERNationwide distribution

MicroVention LVIS stent recalled for sizing defect risk

MicroVention LVIS stent-assist devices may have incorrect dimensions or configuration due to a manufacturing mix-up. Devices that are too large can damage blood vessel walls; devices that are too small may not expand properly or could cause blood clots and stroke.

  • If you implanted one of the affected lots (0000616462, 0000619851, 0000552987, or 0000551725), contact MicroVention immediately for guidance.
  • Do not use any device from the recalled lots.
  • Check the device lot number on your patient record or implant card against the recall list.
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

Sold states
International distribution to the country of China.
Affected count
38
Manufactured in
35 Enterprise, Aliso Viejo, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2200-2026

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