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.
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
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.
The devices may be oversized or undersized due to manufacturing errors. Oversized devices can cause increased vessel wall stress and rupture, while undersized devices may not expand properly or cause blockages leading to neurological issues.
Patients who have received the recalled LVIS devices for vascular procedures are most at risk. Medical professionals using these devices during procedures may also be affected.
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.
Verify the device model code and production lot number against the list provided in the recall notice.
Reach out to Microvention directly for further assistance or to confirm if your device is affected.
The affected devices have model codes 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, and production lots 0000552987, 0000551725, 0000616462, or 0000619851.
Check your device model and production lot against the list provided in the recall notice. Contact Microvention directly for further assistance.
Yes, if the device is oversized, it may cause vessel injury or rupture; if undersized, it may lead to incomplete expansion or neurological complications.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-2200-2026 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-2200-2026 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
