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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 46 of 47

Device	Model / Reference	Registries	Class	Status
HydroFill Helical	100304HFIL-V-A1	FDA UDI	Class II	Active
HydroSoft Helical	100306H2HS-V-N	FDA UDI	Class II	Active
HydroSoft Helical	100202H2HS-V-A2	FDA UDI	Class II	Active
Azur Cx Detachable 18	K123384	FDA 510(k)	Class II	Active
Headway 27 Microcatheter	K110813	FDA 510(k)	Class II	Active
AZUR CX Detachable 18 Peripheral Coil System	K162524	FDA 510(k)	Class II	Active
Wedge Microcatheter	K172014	FDA 510(k)	Class II	Active
Hydroframe (hes)	K090357	FDA 510(k)	Class II	Active
Microplex Coil System-Cosmos	K090891	FDA 510(k)	Class II	Active
Traxcess .007 Mini Guidewire	K161803	FDA 510(k)	Class II	Active
SOFIA EX Intracranial Support Catheter	K230775	FDA 510(k)	Class II	Active
Scepter Mini Occlusion Balloon Catheter	K182829	FDA 510(k)	Class II	Active
Microplex Coil System-Cosmos Model 100933cssr-V, 101036cssr-V, 101141cssr-V, 101245cssr-V	K093919	FDA 510(k)	Class II	Active
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)	K223050	FDA 510(k)	Class II	Active
Microplex Coil System (mcs) And Hydrocoil Embolic System (hes)	K050954	FDA 510(k)	Class II	Active
Azur Pure Peripheral Coil System, Pushable 35	K133626	FDA 510(k)	Class II	Active
Microplex Coil System	K012145	FDA 510(k)	Class II	Active
SOFIA 88 Catheter	K214024	FDA 510(k)	Class II	Active
Traxcess 14 Guidewire	K133725	FDA 510(k)	Class II	Active
Headway 17 Microcatheter	K083343	FDA 510(k)	Class II	Active
Azur Detachable 18	K120630	FDA 510(k)	Class II	Active
Microplex Coil System-Cosmos, Models 81451cs-V, 181555cs-V, 16=81652cs-V	K093358	FDA 510(k)	Class II	Active
Microplex Coil System (mcs) And Hydrocoil Embolic System (hes) With The Hydrolink Syringe Kit	K022735	FDA 510(k)	Class II	Active
Sofia Distal Access Catheter	K142014	FDA 510(k)	Class II	Active
Headway 27 Microcatheter	K142449	FDA 510(k)	Class II	Active
Microplex Coil System-Vector Model 030606xxx-V, 030610xxx-V, 30615xxx-V, 061020xxx-V, 061030xxx-V, 101530xxx-V, 101540xx	K111451	FDA 510(k)	Class II	Active
Azur Pure Peripheral Coil Systems, Pushable 35	K132083	FDA 510(k)	Class II	Active
AZUR Vascular Plug	K191680	FDA 510(k)	Class II	Active
Headway 17 Advanced Microcatheter	K101542	FDA 510(k)	Class II	Active
HydroCoil Embolic System (HES)	K161367	FDA 510(k)	Class II	Active
MV Flow Aspiration Pump (MVFLOWPMP01)	K243638	FDA 510(k)	Class II	Active
Wedge XL Delivery Catheter	K232542	FDA 510(k)	Class II	Active
Traxcess 14ex Guidewire And Traxcess Docking Wire	K093397	FDA 510(k)	Class II	Active
Traxcess 14 SELECT Guidewire	K200547	FDA 510(k)	Class II	Active
Azur Pushable 18 & 35 System	K130577	FDA 510(k)	Class II	Active
Sofia Distal Access Catheter	K131482	FDA 510(k)	Class II	Active
Microplex Coil System (mcs)	K131948	FDA 510(k)	Class II	Active
SOFIA EX Intracranial Support Catheter	K182602	FDA 510(k)	Class II	Active
Modification To: Hydrocoil Embolic System (hes)	K041551	FDA 510(k)	Class II	Active
HydroPearl Microspheres, HydroPearl Microspheres	K150870	FDA 510(k)	Class II	Active
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)	K153594	FDA 510(k)	Class II	Active
Scepter C Occlusion Balloon Catheter	K110741	FDA 510(k)	Class II	Active
Traxcess 7 Mini XSoft Guidewire	K163154	FDA 510(k)	Class II	Active
Hydrocoil Embolic System (hes)	K070656	FDA 510(k)	Class II	Active
Azur Peripheral Hydrocoil Endovascular Embolization System	K091882	FDA 510(k)	Class II	Active
Traxcess 0.014 Hydrophilic Guidewire	K080863	FDA 510(k)	Class II	Active
SOFIA Plus Aspiration Catheter	K173200	FDA 510(k)	Class II	Active
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System	K162999	FDA 510(k)	Class II	Active
Bare Platinum Framing Coil, Model(s) 100408bpfc-V, 100412bpfc-V, 100515bpfc-V100518bpfc-V, 100522bpfc-V, 100618bpfc-V100622b	K082461	FDA 510(k)	Class II	Active
Microplex Coil System- Cosmos	K102365	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.

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.