MicroVention, Inc.
MicroVention, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2024, with 37 FDA device recalls on record.
Top product codes for MicroVention, Inc.
FDA recalls by MicroVention, Inc.
10 most recent of 37- Z-2200-2026 — 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
- Z-0108-2026 — Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X
- Z-2188-2025 — LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
- Z-1121-2025 — MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of wide-necked aneurysms.
- Z-0990-2025 — Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
- Z-3157-2024 — ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suffering from acute ischemic stroke.
- Z-0868-2024 — TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Z-0187-2024 — AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Z-2238-2023 — FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508, FRED4508-PMA, FRED4513-PMA, FRED4518-PMA, FRED4528, FRED4528-PMA, FRED4539, FRED4539-CA, FRED4539-PMA, FRED5009, FRED5009-PMA, FRED5014-PMA, FRED5019-PMA, FRED5029, FRED5029-CA, FRED5029-PMA, FRED5514-CA, FRED5514-PMA, FRED5526-CA, FRED5526-PMA, MV-F351127, MV-F352427, MV-F401227, MV-F401727, MV-F451327, MV-F500927, MV-F501427, MV-F501927, MV-F552627
- Z-0170-2023 — WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by MicroVention, Inc.
- K232542 — Wedge XL Delivery Catheter
- K230775 — SOFIA EX Intracranial Support Catheter
- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K222115 — ISAAC Neurovascular Navigation Catheter
- K223050 — AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
- K214024 — SOFIA 88 Catheter
- K211120 — ERIC Retrieval Device
- K193607 — BOBBY Balloon Guide Catheter
- K201487 — Traxcess 7 Mini Guidewire
- K200547 — Traxcess 14 SELECT Guidewire
- K191680 — AZUR Vascular Plug
- K192684 — HydroPearl Microspheres
- K192135 — VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
- K182829 — Scepter Mini Occlusion Balloon Catheter
- K182602 — SOFIA EX Intracranial Support Catheter
- K173200 — SOFIA Plus Aspiration Catheter
- K172014 — Wedge Microcatheter
- K162999 — V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
- K162524 — AZUR CX Detachable 18 Peripheral Coil System
- K163154 — Traxcess 7 Mini XSoft Guidewire
- K161803 — Traxcess .007 Mini Guidewire
- K161367 — HydroCoil Embolic System (HES)
- K161452 — MicroPlex Coil System (MCS) - HyperSoft 3D
- K153594 — MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
- K153053 — Traxcess Pro 14 Guidewire
- K150870 — HydroPearl Microspheres, HydroPearl Microspheres
- K151358 — AZUR CX Detachable 35 Coils
- K150958 — LifePearl Microshperes
- K150366 — SOFIA 6F Catheter
- K142449 — Headway 27 Microcatheter
- K142014 — SOFIA DISTAL ACCESS CATHETER
- K133725 — TRAXCESS 14 GUIDEWIRE
- K133626 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
- K132952 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K131482 — SOFIA DISTAL ACCESS CATHETER
- K132083 — AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35
- K131948 — MICROPLEX COIL SYSTEM (MCS)
- K132317 — MICROPLEX COIL SYSTEM (MCS), VFC
- K130577 — AZUR PUSHABLE 18 & 35 SYSTEM
- K122543 — AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35
- K123384 — AZUR CX DETACHABLE 18
- K122316 — AZUR DETACHABLE 35
- K121785 — SCEPTER C OCCLUSION BALLOON CATHETER
- K120917 — HEADWAY DUO MICROCATHETER
- K120908 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K120630 — AZUR DETACHABLE 18
- K113698 — SCEPTER XC OCCLUSION BALLOON CATHETER
- K113457 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K112181 — HYDROCOIL(R) EMBOLIC SYSTEM (HES)
- K110741 — SCEPTER C OCCLUSION BALLOON CATHETER
- K112226 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K111451 — MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
- K110813 — HEADWAY 27 MICROCATHETER
- K111307 — AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
- K103758 — MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
- K102365 — MICROPLEX COIL SYSTEM- COSMOS
- K101542 — HEADWAY 17 ADVANCED MICROCATHETER
- K100454 — HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
- K093647 — TRAXCESS DOCKING WIRE
- K093919 — MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
- K093358 — MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
- K093397 — TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
- K093160 — HEADWAY 21 MICROCATHETER, MODEL: MC212150S
- K093002 — AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610
- K091882 — AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
- K091641 — HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
- K090891 — MICROPLEX COIL SYSTEM-COSMOS
- K090357 — HYDROFRAME (HES)
- K090168 — AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
- K090001 — V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
- K082385 — CHAPERON GUIDING CATHETER
- K083343 — HEADWAY 17 MICROCATHETER
- K082461 — BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
- K080666 — HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
- K080863 — TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
- K071939 — HYDROCOIL EMBOLIC SYSTEMS (HES)
- K070656 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K050954 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)
- K041551 — MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
- K033836 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K032590 — MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
- K022735 — MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT
- K020434 — MICROPLEX COIL SYSTEM (MCS)
- K021914 — MICROPLEX COIL SYSTEMS (MCS)
- K012145 — MICROPLEX COIL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.