MICROVENTION INC. Recall: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal
MICROVENTION INC. Recall: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: MICROVENTION INC.; Product: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22
| Recalling firm | MICROVENTION INC. |
|---|---|
| Product | 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 |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | International distribution to the country of China. |
| Recall initiated | 20260406 |
| Recall number | Z-2200-2026 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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