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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 47 of 47

Device	Model / Reference	Registries	Class	Status
Chaperon Guiding Catheter	K082385	FDA 510(k)FDA UDI	Class II	Active
Hydrocoil Embolic System (hydrosoft) And Microplex Coil System (hypersoft)	K091641	FDA 510(k)	Class II	Active
Headway Duo Microcatheter	K120917	FDA 510(k)	Class II	Active
Traxcess Docking Wire	K093647	FDA 510(k)	Class II	Active
Scepter Xc Occlusion Balloon Catheter	K113698	FDA 510(k)	Class II	Active
Azur Detachable 35 Platinum Coil System	K111307	FDA 510(k)	Class II	Active
Headway 21 Microcatheter, Model: Mc212150s	K093160	FDA 510(k)	Class II	Active
MicroPlex Coil System (MCS) - HyperSoft 3D	K161452	FDA 510(k)	Class II	Active
Traxcess Pro 14 Guidewire	K153053	FDA 510(k)	Class II	Active
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)	K192135	FDA 510(k)	Class II	Active
Microplex Coil System (mcs)	K020434	FDA 510(k)	Class II	Active
Microplex Coil Systems (mcs)	K021914	FDA 510(k)	Class II	Active
ISAAC Neurovascular Navigation Catheter	K222115	FDA 510(k)	Class II	Active
LifePearl Microshperes	K150958	FDA 510(k)	Class II	Active
Microplex Coil System (mcs), Hydrocoil Embolic System (hes)	K132952	FDA 510(k)	Class II	Active
Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610	K093002	FDA 510(k)	Class II	Active
Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415	K090168	FDA 510(k)	Class II	Active
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190, PNP6514C-190)	K222694	FDA 510(k)	Class II	Active
Hydrocoil Embolic System (hes)	K120908	FDA 510(k)	Class II	Active
Microplex Coil System (mcs), Hydrocoil Embolic System (hes)	K032590	FDA 510(k)	Class II	Active
Hydrosoft And Hydrosoft Plus Embolization Coil Systems	K080666	FDA 510(k)	Class II	Active
SOFIA 6F Catheter	K150366	FDA 510(k)	Class II	Active
Microplex Coil System (mcs), Vfc	K132317	FDA 510(k)	Class II	Active
HydroPearl Microspheres	K192684	FDA 510(k)	Class II	Active
Scepter C Occlusion Balloon Catheter	K121785	FDA 510(k)	Class II	Active
Traxcess 7 Mini Guidewire	K201487	FDA 510(k)	Class II	Active
ERIC Retrieval Device	K211120	FDA 510(k)	Class II	Active
Azur Detachable 35	K122316	FDA 510(k)	Class II	Active
Hydrocoil Embolic System (hes)	K113457	FDA 510(k)	Class II	Active
BOBBY Balloon Guide Catheter	K193607	FDA 510(k)	Class II	Active
Hydrocoil Embolic System (hes)	K033836	FDA 510(k)	Class II	Active
Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable 35	K122543	FDA 510(k)	Class II	Active
Hydrocoil Embolic Systems (hes)	K071939	FDA 510(k)	Class II	Active
V-Grip Plus Detachment Controller, Model Vg503	K090001	FDA 510(k)	Class II	Active
Hydrocoil(r) Embolic System (hes)	K112181	FDA 510(k)	Class II	Active
Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10	K103758	FDA 510(k)	Class II	Active
Hydrocoil Embolic System (hes)	K112226	FDA 510(k)	Class II	Active
AZUR CX Detachable 35 Coils	K151358	FDA 510(k)	Class II	Active
Hydrocoil Embolic System-Hydroframe Model 100931hfm-V, 101243hfm-V, 180827hfm-V, 181139hfm-V, 181445hfm-V, 181850hfm-V	K100454	FDA 510(k)	Class II	Active
Roadsaver/CASPER Carotid Stent Device	P210030	FDA PMA	Class III	Active
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.	P170013	FDA PMA	Class III	Active
Woven EndoBridge (WEB) Aneurysm Embolization System	P170032	FDA PMA	Class III	Active
Flow Re-Direction Endoluminal Device (FRED) System	P180027	FDA PMA	Class III	Active

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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.