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MICROVENTION INC.

Last updated May 24, 2026

Information

Country: US
Address: —
Website: microvention.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(714)247-8000
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 003263105

Catalogue (2343)

Page 3 of 47

Device	Model / Reference	Registries	Class	Status
Stent	FREDX4525-PMA	FDA UDI	Class III	Active
HydroFill Helical	100830HFIL-V-A1	FDA UDI	Class II	Active
Azur	45-480505-02	FDA UDI	Class II	Active
HydroSoft 3D	100206HFRM-V-3D-A2	FDA UDI	Class II	Active
HydroFill Helical	100820HFIL-V-A	FDA UDI	Class II	Active
Azur Pushable Helical	45-250814	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100931HFRM-V-A2	FDA UDI	Class II	Active
MicroPlex Cosmos	180827CS-V	FDA UDI	Class II	Active
WEB Aneurysm Embolization System	W4-4-3-MVI-3	FDA UDI	Class III	Active
V-Trak	7210-0404-A2	FDA UDI	Class II	Active
HydroSoft Helical	100256H2HS-V	FDA UDI	Class II	Active
Traxcess	GW1420040SK	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100833HFRM-V-A1	FDA UDI	Class II	Active
MicroPlex Helical Regular	100720HC-R-V	FDA UDI	Class II	Active
MicroPlex Compass Complex	100254CMSR-V	FDA UDI	Class II	Active
HydroSoft Helical	100408H2HS-V[ER]	FDA UDI	Class II	Active
V-Trak	100310HCSR-S-V-A2	FDA UDI	Class II	Active
MicroPlex Helical Soft	100310HCSR-S-V	FDA UDI	Class II	Active
MicroPlex Helical Soft	100208HC-S-V-A1	FDA UDI	Class II	Active
HydroPearl	HP2S0800	FDA UDI	Class II	Active
MicroPlex Cosmos	100518CSSR-V	FDA UDI	Class II	Active
HydroSoft Helical	100406H2HS-V-A2	FDA UDI	Class II	Active
Helical Regular 18 Advanced	8618-1030	FDA UDI	Class II	Active
HydroFill Advanced	7310-0930	FDA UDI	Class II	Active
HydroFrame Framing Coil	181139HFRM-V	FDA UDI	Class II	Active
Headway Advanced	MC17215090X	FDA UDI	Class II	Active
Azur Detachable Framing Coil	45-681844	FDA UDI	Class II	Active
HydroSoft Helical	100510H2HS-V-A2	FDA UDI	Class II	Active
Azur Detachable Helical HydroCoil	45-480305	FDA UDI	Class II	Active
HyperSoft 3D Advanced	8410-0304	FDA UDI	Class II	Active
Cosmos 18 Advanced	8218-0723-A1	FDA UDI	Class II	Active
MicroPlex Helical Soft	100310HCSR-S-V-A1	FDA UDI	Class II	Active
V-Trak	8310-1540-A2	FDA UDI	Class II	Active
HydroSoft Helical	100406H2HS-V-A1	FDA UDI	Class II	Active
HydroSoft Helical	100406H2HS-V[ER]	FDA UDI	Class II	Active
MicroPlex Compass Complex	100510CMSR-V-A	FDA UDI	Class II	Active
Azur Detachable Helical HydroCoil	45-451520	FDA UDI	Class II	Active
Lvis	212517-LVIS-D-PMA	FDA UDI	Class III	Active
HydroFrame 18 Advanced	7118-1850	FDA UDI	Class II	Active
HyperSoft Advanced	8510-0606-A1	FDA UDI	Class II	Active
MicroPlex Helical Regular	181230HC-R-V	FDA UDI	Class II	Active
MicroPlex VFC	VFC101540-V	FDA UDI	Class II	Active
Azur	45-480305-02	FDA UDI	Class II	Active
HydroSoft Helical	100310H2HS-V-A2	FDA UDI	Class II	Active
Traxcess Guidewire	GW1420040-OUS	FDA UDI	Class II	Active
HydroSoft Helical	100306H2HS-V	FDA UDI	Class II	Active
Azur Detachable Helical HydroCoil	45-450815	FDA UDI	Class II	Active
HydroFill Helical	100408HFIL-V-A2	FDA UDI	Class II	Active
HydroFill Helical	100620HFIL-V-A1	FDA UDI	Class II	Active
Lvis	212931-LVIS-D-PMA	FDA UDI	Class III	Active

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Authorised Representatives

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Importers

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Authorities

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FDA Recalls (37)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 6, 2026	Z-2200-2026	—	open, classified	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
Sep 5, 2025	Z-0108-2026	—	open, classified	Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
May 29, 2025	Z-2188-2025	—	open, classified	Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Dec 11, 2024	Z-1121-2025	—	open, classified	Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Dec 2, 2024	Z-0990-2025	—	open, classified	Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Aug 5, 2024	Z-3157-2024	—	open, classified	Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Dec 21, 2023	Z-0868-2024	—	open, classified	Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Aug 24, 2023	Z-0187-2024	—	open, classified	Peripheral coil system detachable has a potential of unsealed pouch packaging.
Jun 7, 2023	Z-2238-2023	—	open, classified	Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Sep 21, 2022	Z-0170-2023	—	open, classified	Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the implant device, which could cause delays and excessive manipulation that may cause the implant to move and damage vessels
Oct 20, 2021	Z-0202-2022	—	terminated	Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Apr 21, 2021	Z-1829-2021	—	terminated	Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Apr 21, 2021	Z-1830-2021	—	terminated	Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Apr 21, 2021	Z-1828-2021	—	terminated	Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Nov 24, 2019	Z-1222-2020	—	terminated	The devices may be missing the implant coil.
Nov 24, 2019	Z-1220-2020	—	terminated	The devices may be missing the implant coil.
Nov 24, 2019	Z-1221-2020	—	terminated	The devices may be missing the implant coil.
Nov 24, 2019	Z-1225-2020	—	terminated	The devices may be missing the implant coil.
Nov 24, 2019	Z-1223-2020	—	terminated	The devices may be missing the implant coil.
Nov 24, 2019	Z-1224-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1394-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1398-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1403-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1395-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1393-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1396-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1401-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1399-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1405-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1407-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1406-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1397-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1402-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1404-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1392-2020	—	terminated	The devices may be missing the implant coil.
Nov 22, 2019	Z-1400-2020	—	terminated	The devices may be missing the implant coil.
Aug 7, 2017	Z-3103-2017	—	terminated	There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.