{"url_path":"/fda/device/recalls/Z-2200-2026","section_key":"summary","section_title":"DEVICE Recall: MICROVENTION INC. — 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","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-06","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2200-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"MICROVENTION INC."},"word_count":134,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2200-2026\n\n**Recalling firm:** MICROVENTION INC.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-06\n**Report date:** 2026-05-20\n\n## Product\nLVIS 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\n\n## Reason\nStent-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\n\n## Affected lots\nLots: 0000616462, 0000619851, 0000552987, 0000551725.  UDI: (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115893(11)240325(17)270228(10)0000552987, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240325(17)270228(10)0000551725, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115930(11)240610(17)270531(10)0000616462, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851, (01)00842429115961(11)240610(17)270531(10)0000619851,\n\n## Distribution\nInternational distribution to the country of China."}