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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 2 of 47

Device	Model / Reference	Registries	Class	Status
HydroFill Helical	100408HFIL-V-N	FDA UDI	Class II	Active
MicroPlex Helical Regular	101030HCSR-R-V-A1	FDA UDI	Class II	Active
Lvis	214049-LVIS	FDA UDI	Unclassified	Active
MicroPlex Cosmos	181036CS-V	FDA UDI	Class II	Active
MicroPlex Helical Regular	100730HC-R-V-A1	FDA UDI	Class II	Active
MicroPlex Helical Regular	100720HCSR-R-V	FDA UDI	Class II	Active
HyperSoft 3D Advanced	8410-0153	FDA UDI	Class II	Active
Complex 10 Advanced	8110-0307-A1	FDA UDI	Class II	Active
HydroSoft Advanced	7210-0206-A1	FDA UDI	Class II	Active
HydroCoil Helical	181620HES-V	FDA UDI	Class II	Active
Stent	FRED5514-PMA	FDA UDI	Class III	Active
MicroPlex Helical Soft	100408HCSR-S-V-A1	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100515HFRM-V-A1	FDA UDI	Class II	Active
Azur Detachable Framing Coil	45-680410	FDA UDI	Class II	Active
Azur Vacular Plug	45-181000	FDA UDI	Class II	Active
HydroFrame 10 Advanced	7110-0931-A1	FDA UDI	Class II	Active
HydroSoft 3D	7110-0256-3D-A2	FDA UDI	Class II	Active
HydroFrame 10 Advanced	7110-0202	FDA UDI	Class II	Active
HydroFill Helical	100930HFIL-V-A2	FDA UDI	Class II	Active
Azur Pure Helical	45-080606	FDA UDI	Class II	Active
Lvis	213015-LVIS	FDA UDI	Unclassified	Active
Azur Detachable Helical HydroCoil	45-480815	FDA UDI	Class II	Active
MicroPlex Helical Regular	100520HC-R-V-A1	FDA UDI	Class II	Active
Stent	FREDX4520-PMA	FDA UDI	Class III	Active
Web	W5-5-2-MVI-3	FDA UDI	Class III	Active
HydroSoft Helical	100508H2HS-V-A2	FDA UDI	Class II	Active
HydroSoft 3D	100256HFRM-V-3D-A2	FDA UDI	Class II	Active
HydroFill Helical	100202HFIL-V-N	FDA UDI	Class II	Active
HydroSoft Helical	100306H2HS-V-A1	FDA UDI	Class II	Active
HydroFill Advanced	7310-0515	FDA UDI	Class II	Active
HydroSoft Helical	100203H2HS-V	FDA UDI	Class II	Active
HydroSoft Helical	100104H2HS-V	FDA UDI	Class II	Active
MicroPlex Helical Soft	100308HCSR-S-V	FDA UDI	Class II	Active
HydroSoft 3D	7110-0304-3D-A2	FDA UDI	Class II	Active
Azur Detachable Framing Coil	45-682050	FDA UDI	Class II	Active
MicroPlex Compass Complex	182060CM-V	FDA UDI	Class II	Active
Cosmos 10 Advanced	8210-0202	FDA UDI	Class II	Active
MicroPlex Compass Complex	100412CM-V	FDA UDI	Class II	Active
HyperSoft 3D Advanced	8410-0408-A1	FDA UDI	Class II	Active
V-Trak	100306HCSR-S-V-A2	FDA UDI	Class II	Active
Sofia 6F-131cm STR	DA6131ST	FDA UDI	Class II	Active
HydroFill Helical	100206HFIL-V-N	FDA UDI	Class II	Active
Azur Detachable Helical HydroCoil	45-451230	FDA UDI	Class II	Active
Chaperon Guiding Catheter	GC595M1JB	FDA UDI	Class II	Active
V-Trak	7310-0720-A2	FDA UDI	Class II	Active
V-Trak	7210-0204-A2	FDA UDI	Class II	Active
MicroPlex Helical Regular	100520HC-R-V	FDA UDI	Class II	Active
HyperSoft Advanced	8510-0152-A1	FDA UDI	Class II	Active
Lvis	212917-LVIS-D-HDE	FDA UDI	Unclassified	Active
Stent	FRED2513-PMA	FDA UDI	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.