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Stent
Microvention, Inc. · Model LEV3517-PMA · UDI-DI 00842429117828
QCA
Prescription
0
510(k) clearances
806
Adverse events (10 deaths)
2
Recalls
7
Facilities
Description
LVIS EVO
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | MICROVENTION INC. | 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 |
| 2024-12-11 | MICROVENTION INC. | Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. |
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