MICROVENTION INC. — Class II: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length
MicroVention Inc. is conducting a Class II recall of specific LVIS Intraluminal Support Device models due to potential dimensional nonconformance or incorrect device configurations resulting from commingling during manufacturing.
This recall affects MicroVention Inc., healthcare providers using specific LVIS Intraluminal Support Device models (REF 214022-CAS, 214518-CAS, 213517-CAS), and regulatory/quality departments managing neurovascular implantable devices.
The manufacturing error presents significant clinical risks; oversized devices may cause vessel injury or rupture, while undersized devices may lead to thrombosis or ischemic events. For regulatory professionals, this underscores the importance of stringent segregation protocols in manufacturing to prevent commingling and the necessity of robust final dimensional inspections for implantable stents.
Quality teams should verify inventory against the specific REF numbers and dimensions provided. Regulatory and manufacturing leads should evaluate commingling risks in shared production lines and review dimensional inspection protocols to ensure conformance to specifications.
Class II. Reason: 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. 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. Firm: MICROVENTION INC. (Aliso Viejo CA United States). Status: Ongoing.
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