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MICROVENTION INC.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BG recall (Z-2912-2026)MICROVENTION INC.2026-08-07
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length recall (Z-2200-2026)MICROVENTION INC.2026-05-14
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED402 recall (Z-0108-2026)MICROVENTION INC.2025-10-10
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 mi recall (Z-2188-2025)MICROVENTION INC.2025-07-28
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 m recall (Z-1121-2025)MICROVENTION INC.2025-02-07
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: M recall (Z-0990-2025)MICROVENTION INC.2025-01-17
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mecha recall (Z-3157-2024)MICROVENTION INC.2024-09-17
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 recall (Z-0868-2024)MICROVENTION INC.2024-01-31
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 recall (Z-0187-2024)MICROVENTION INC.2023-10-27
FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED recall (Z-2238-2023)MICROVENTION INC.2023-07-27
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolizatio recall (Z-0170-2023)MICROVENTION INC.2022-11-02

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Every clearance here is in the API, with alerts when new ones post.