Data / Medical devices / United States / MicroVention, Inc.

MicroVention, Inc.: FDA-registered device maker in Aliso Viejo, CA, United States, 72 510(k) clearances and 4 PMA approvals

Name: MicroVention, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MicroVention, Inc. is registered with the FDA (registration 3013556777) in Aliso Viejo, CA, United States. It lists 24 device types. The FDA files 72 510(k) clearances and 4 PMA approvals under its listings, the newest dated September 3, 2026. 17 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013556777
Address: 35 Enterprise, Aliso Viejo, CA, United States, 92656
Owner or operator: MicroVention Inc. (10033879)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: October 13, 2010
Registered through: 2027
Brand names listed: 12V AZUR Detachment Controller, 12V V-Grip Detachment Controller, 9V V-Grip Detachment Controller, AZUR CX Coil System - Detachable 18, AZUR CX Detachable 18 Peripheral Coil System, AZUR CX Peripheral Coil System- Detachable 35, AZUR Detachable 18, AZUR Detachable 18 LE and more

Devices it lists

Device	Product code	Class	Role	Source
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	NOY	2	Manufacturer	accessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine Fibroids	NAJ	2	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Specification developer	accessdata.fda.gov
Aspiration Thrombectomy Catheter	QEZ	2	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Manufacturer for export	accessdata.fda.gov
Dural Arteriovenous Fistula Liquid Embolic	SGF	f	Manufacturer	accessdata.fda.gov
Guide, Wire, Catheter, Neurovasculature	MOF	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Intracranial Aneurysm Flow Diverter	OUT	3	Manufacturer	accessdata.fda.gov
Intracranial Coil-Assist Stent	QCA	3	Repackager or relabeler, Specification developer	accessdata.fda.gov
Intrasaccular Flow Disruption Device	OPR	3	Manufacturer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Specification developer	accessdata.fda.gov
Stent, Carotid	NIM	3	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Temporary Carotid Catheter For Embolic Capture	NTE	2	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 3, 2026	K254035	Mayumi Thrombectomy System	QEZ	Substantially Equivalent	MicroVention, Inc., d/b/a Terumo Neuro	accessdata.fda.gov
June 13, 2025	K243638	MV Flow Aspiration Pump (MVFLOWPMP01)	JCX	Substantially Equivalent	Microvention	accessdata.fda.gov
May 16, 2024	K232542	Wedge XL Delivery Catheter	QJP	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 14, 2023	K230775	SOFIA EX Intracranial Support Catheter	QJP	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 27, 2023	K222694	EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)	NTE	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 10, 2023	K222115	ISAAC Neurovascular Navigation Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 21, 2022	K223050	AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 12, 2022	K214024	SOFIA 88 Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 31, 2022	K211120	ERIC Retrieval Device	NRY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
July 21, 2020	K193607	BOBBY Balloon Guide Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
July 2, 2020	K201487	Traxcess 7 Mini Guidewire	MOF	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 16, 2020	K200547	Traxcess 14 SELECT Guidewire	MOF	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 20, 2020	K191680	AZUR Vascular Plug	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 22, 2020	K192684	HydroPearl Microspheres	NOY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 24, 2019	K192135	VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 21, 2019	K192625	PG Pro Microcatheter	DQY	Substantially Equivalent	MicroVention, Inc. A TERUMO Group Company	accessdata.fda.gov
July 10, 2019	K182829	Scepter Mini Occlusion Balloon Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
May 15, 2019	K182602	SOFIA EX Intracranial Support Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 11, 2018	K173200	SOFIA Plus Aspiration Catheter	NRY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 5, 2018	K172014	Wedge Microcatheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 29, 2017	K162999	V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 3, 2017	K162524	AZUR CX Detachable 18 Peripheral Coil System	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 30, 2016	K161803	Traxcess .007 Mini Guidewire	MOF	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 31, 2016	K161452	MicroPlex Coil System (MCS) - HyperSoft 3D	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 31, 2016	K161367	HydroCoil Embolic System (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 22, 2016	K153594	MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 25, 2015	K151358	AZUR CX Detachable 35 Coils	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 27, 2015	K150366	SOFIA 6F Catheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 26, 2015	K142449	Headway 27 Microcatheter	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
October 10, 2014	K142014	SOFIA DISTAL ACCESS CATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
July 31, 2014	K133725	TRAXCESS 14 GUIDEWIRE	MOF	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 20, 2013	K133626	AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 19, 2013	K132952	MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 22, 2013	K131482	SOFIA DISTAL ACCESS CATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
October 28, 2013	K132083	AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
October 4, 2013	K131948	MICROPLEX COIL SYSTEM (MCS)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 20, 2013	K132317	MICROPLEX COIL SYSTEM (MCS), VFC	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 17, 2013	K130577	AZUR PUSHABLE 18 & 35 SYSTEM	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 28, 2012	K123384	AZUR CX DETACHABLE 18	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 29, 2012	K122316	AZUR DETACHABLE 35	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 10, 2012	K121785	SCEPTER C OCCLUSION BALLOON CATHETER	MJN	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 2, 2012	K120917	HEADWAY DUO MICROCATHETER	DQO	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 25, 2012	K120908	HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 28, 2012	K120630	AZUR DETACHABLE 18	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 16, 2011	K113457	HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 29, 2011	K112226	HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
September 20, 2011	K111451	MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 5, 2011	K110813	HEADWAY 27 MICROCATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 15, 2011	K111307	AZUR DETACHABLE 35 PLATINUM COIL SYSTEM	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 28, 2011	K103758	MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 18, 2010	K102365	MICROPLEX COIL SYSTEM- COSMOS	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
August 6, 2010	K101542	HEADWAY 17 ADVANCED MICROCATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 22, 2010	K100454	HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
February 24, 2010	K093647	TRAXCESS DOCKING WIRE	DQX	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 21, 2010	K093919	MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 15, 2010	K093358	MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 17, 2009	K093397	TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE	DQX	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
November 5, 2009	K093160	HEADWAY 21 MICROCATHETER, MODEL: MC212150S	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
October 28, 2009	K093002	AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
July 8, 2009	K091882	AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 30, 2009	K091641	HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 22, 2009	K090891	MICROPLEX COIL SYSTEM-COSMOS	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
April 10, 2009	K090357	HYDROFRAME (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
March 12, 2009	K090168	AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 11, 2008	K082385	CHAPERON GUIDING CATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
December 4, 2008	K083343	HEADWAY 17 MICROCATHETER	DQY	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
October 2, 2008	K082461	BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
July 11, 2008	K080666	HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 11, 2008	K071939	HYDROCOIL EMBOLIC SYSTEMS (HES)	KRD	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 15, 2007	K070656	HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
June 28, 2005	K050954	MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)	HCG	Substantially Equivalent	MicroVention, Inc.	accessdata.fda.gov
January 5, 2000	K994253	VACLOK SYRINGE	FMF	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 20, 2024	P210030	Roadsaver/CASPER Carotid Stent Device	NIM	2	July 7, 2026	accessdata.fda.gov
December 16, 2019	P180027	Flow Re-Direction Endoluminal Device (FRED®) System	OUT	13	November 2, 2025	accessdata.fda.gov
December 31, 2018	P170032	Woven EndoBridge (WEB) Aneurysm Embolization System	OPR	20	May 28, 2026	accessdata.fda.gov
May 30, 2018	P170013	Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.	QCA	12	September 16, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 30, 2026	98909	Class II	Ongoing	BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the periphe	Due to an increase rate of balloon pinhole defects.	accessdata.fda.gov
April 6, 2026	98755	Class II	Ongoing	LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm	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	accessdata.fda.gov
September 5, 2025	97580	Class II	Ongoing	Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE,	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 h	accessdata.fda.gov
May 29, 2025	96915	Class II	Ongoing	LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400	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 patien	accessdata.fda.gov
December 11, 2024	96114	Class II	Ongoing	MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device provi	Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.	accessdata.fda.gov
December 2, 2024	95962	Class II	Ongoing	Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846	Sterility assurance; microcatheter inner packaging may contain incomplete seal.	accessdata.fda.gov
August 5, 2024	95151	Class II	Ongoing	ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vasculature in patients suff	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.	accessdata.fda.gov
December 21, 2023	93692	Class II	Ongoing	TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600	Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.	accessdata.fda.gov
August 24, 2023	93147	Class II	Ongoing	AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324	Peripheral coil system detachable has a potential of unsealed pouch packaging.	accessdata.fda.gov
June 7, 2023	92580	Class II	Ongoing	FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FR	Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.	accessdata.fda.gov
September 21, 2022	90966	Class II	Ongoing	WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.	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 caus	accessdata.fda.gov
October 20, 2021	88892	Class II	Terminated	Aspiration Syringe Kit, REF: MVSK60	Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.	accessdata.fda.gov
April 21, 2021	88024	Class III	Terminated	VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.	Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.	accessdata.fda.gov
November 24, 2019	84585	Class II	Terminated	Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-48031	The devices may be missing the implant coil.	accessdata.fda.gov
November 22, 2019	84727	Class II	Terminated	MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS	The devices may be missing the implant coil.	accessdata.fda.gov
August 7, 2017	77880	Class II	Terminated	MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.	There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.	accessdata.fda.gov
June 23, 2006	36193	Not yet classified	Terminated	TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205	Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance.	accessdata.fda.gov

Compare with other makers

Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.