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MICROVENTION INC.

Last updated May 24, 2026

What MICROVENTION INC. makes

Microvention Inc. manufactures neurovascular embolization coils, non-neurovascular embolization coils, bare-metal intracranial vascular stents, vascular microcatheters, vascular guide-catheters, cardiac/peripheral vascular guidewires, embolization particles, and adenovirus immunoglobulin A (IgA) antibody IVD calibrators.

The company's portfolio includes Class II, Class III, and unclassified devices listed in the FDA UDI registry, and it is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 6 of 47

Device	Model / Reference	Registries	Class	Status
HydroFill Helical	100515HFIL-V-A	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100619HFRM-V-A2	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100817HFRM-V-A	FDA UDI	Class II	Active
Chaperon Guiding Catheter	GC595M2VT	FDA UDI	Class II	Active
HydroSoft Helical	100515H2HS-V-A2	FDA UDI	Class II	Active
Lvis	212912-LVIS-D-HDE	FDA UDI	Unclassified	Active
Headway	MC212156S	FDA UDI	Class II	Active
V-Trak	8410-0408-A2	FDA UDI	Class II	Active
Azur	45-880035	FDA UDI	Class II	Active
HydroFrame 18 Advanced	7118-1243-A1	FDA UDI	Class II	Active
V-Trak	8310-2040-A2	FDA UDI	Class II	Active
Sofia	DA6131ST-ASP-US	FDA UDI	Class II	Active
Headway Advanced	MC172150JX	FDA UDI	Class II	Active
MicroPlex Helical Regular	180830HC-R-V	FDA UDI	Class II	Active
Sofia 6F-125cm STR	DA6125ST	FDA UDI	Class II	Active
Chaperon Guiding Catheter	GC595M1SI	FDA UDI	Class II	Active
V-Trak	8210-0254-A2	FDA UDI	Class II	Active
HydroFill Advanced	7310-0610-A1	FDA UDI	Class II	Active
HydroSoft Advanced	7210-0152	FDA UDI	Class II	Active
Stent	FRED4518-PMA	FDA UDI	Class III	Active
V-Trak	7210-0308-A2	FDA UDI	Class II	Active
HyperSoft Advanced	8510-0254	FDA UDI	Class II	Active
HydroFrame 10 Advanced	7110-0817	FDA UDI	Class II	Active
Azur Pushable Helical	45-250810	FDA UDI	Class II	Active
HydroSoft Helical	100506H2HS-V-A	FDA UDI	Class II	Active
Cosmos 10 Advanced	8210-1036-A1	FDA UDI	Class II	Active
MicroPlex Helical Regular	100930HCSR-R-V	FDA UDI	Class II	Active
HydroFrame 10 Advanced	100410HFRM-V-A2	FDA UDI	Class II	Active
HydroFrame Framing Coil	101243HFRM-V	FDA UDI	Class II	Active
Cosmos 18 Advanced	8218-0619	FDA UDI	Class II	Active
HydroFill Helical	101230HFIL-V-A	FDA UDI	Class II	Active
HydroFrame 10 Advanced	7110-0931	FDA UDI	Class II	Active
Cosmos 18 Advanced	8218-0827-A1	FDA UDI	Class II	Active
MicroPlex Helical Soft	100303HC-S-V	FDA UDI	Class II	Active
HydroSoft Helical	100404H2HS-V-A	FDA UDI	Class II	Active
MicroPlex Helical Regular	100920HC-R-V-A1	FDA UDI	Class II	Active
HydroPearl	8HP2S75	FDA UDI	Class II	Active
HydroSoft Helical	100308H2HS-V-A2	FDA UDI	Class II	Active
HydroFrame Framing Coil	181139HFRM-V-A2	FDA UDI	Class II	Active
Azur Detachable Helical HydroCoil	45-450510	FDA UDI	Class II	Active
HydroSoft Helical	100254H2HS-V	FDA UDI	Class II	Active
Stent	FRED3021-PMA	FDA UDI	Class III	Active
V-Trak	8218-1652-A2	FDA UDI	Class II	Active
MicroPlex VFC	VFC152060-V	FDA UDI	Class II	Active
VFC Advanced	8310-1020-A1	FDA UDI	Class II	Active
HydroSoft Advanced	7210-0506-A1	FDA UDI	Class II	Active
VIA Microcatheter	VIA-17-154-90-AL	FDA UDI	Class II	Active
HydroSoft Helical	100620H2HS-V-A	FDA UDI	Class II	Active
HydroSoft Advanced	7210-0408	FDA UDI	Class II	Active
MicroPlex Helical Soft	180308HC-S-V	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

There are 37 recall records for MICROVENTION INC., with the earliest initiated on 2017-08-07 and the most recent on 2026-04-06. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include potential issues with PTFE material encasement, missing implant coils, manufacturing issues related to tantalum length or attachment pattern, incorrect labeling for U.S. distribution, incorrect inner stent length, out-of-specification tunnel opening dimensions in detachment controllers, deviation from prescribed manufacturing and quality processes, incomplete seals in microcatheter inner packaging, incorrect expiration dates on retrieval device labels, potential delamination of hydrophilic coating on guidewires, and potential for unsealed pouch packaging in peripheral coil systems.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.