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Micro Therapeutics, Inc.

Last updated May 24, 2026

What Micro Therapeutics, Inc. makes

Micro Therapeutics, Inc. manufactures neurovascular embolization coils, including detachable systems for treating cerebral aneurysms, and bare-metal intracranial vascular stents for stabilizing blood vessels in the brain. Their portfolio also includes non-neurovascular embolization coils for vascular occlusions outside the brain, as well as peripheral vascular intervention tools such as infusion catheters, thrombectomy wires, guide-catheters, and microcatheters for interventional radiology procedures. Additionally, they produce image-guided intravascular occluding balloon catheters for targeted vascular blockages.

The company’s devices are classified under FDA’s Class II and Class III regulatory categories, with most listed in the FDA’s Unique Device Identifier (UDI) database. Their products are designed for use in the United States, adhering to applicable medical device regulations.

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

Information

Country: US
Address: —
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 826110710

Catalogue (3141)

Page 2 of 63

Device	Model / Reference	Registries	Class	Status
Axium	QC-3-8-HELIX	FDA UDI	Class II	Active
Axium™ Prime Detachable Coil System	APB-1-3-3D-ES	FDA UDI	Class II	Active
Axium™ Detachable Coil System	PC-8-20-HELIX	FDA UDI	Class II	Active
AxiumTM	QC-3.5-6-3D	FDA UDI	Class II	Active
Concerto Versa™	CV-14-40	FDA UDI	Class II	Active
Concerto Detachable Coil System	NV-3-8-HELIX	FDA UDI	Class II	Active
Axium Detachable Coil System	QC-3-8-HELIX	FDA UDI	Class II	Active
Cragg-McNamara	41050-01	FDA UDI	Class II	Active
Axium Prime	APB-6-15-3D-SS	FDA UDI	Class II	Active
ConcertoTM	NV-9-30-HELIX	FDA UDI	Class II	Active
Axium™ Prime Detachable Coil System	APB-1-1-HX-ES	FDA UDI	Class II	Active
SolitaireTM	SFR3-4-20-10	FDA UDI	Class II	Active
Solitaire™ X-PACK	XPACK323	FDA UDI	Class II	Active
Cragg Mc-Namara Valved Infusion Catheter	41037-01	FDA UDI	Class II	Active
PipelineTM Flex Embolization Device with Shield TechnologyTM	PED2-325-30	FDA UDI	Class III	Active
PhenomTM 21 Catheter	FG13160-0615-1S	FDA UDI	Class II	Active
ConcertoTM	PV-9-30-3D	FDA UDI	Class II	Active
Cragg-McNamara	41057-01	FDA UDI	Class II	Active
Axium™ Prime Detachable Coil System	FC-14-40-3D	FDA UDI	Class II	Active
ConcertoTM	NV-5-15-HELIX	FDA UDI	Class II	Active
Pipeline	FA-71375-35	FDA UDI	Class III	Active
UltraFlow	105-5066	FDA UDI	Class II	Active
Cragg-McNamara	41056-01	FDA UDI	Class II	Active
Axium PrimeTM	FC-8-30-3D	FDA UDI	Class II	Active
Pipeline	FA-71300-30	FDA UDI	Class III	Active
Pipeline	FA-77275-20	FDA UDI	Class III	Active
Axium Detachable Coil System	QC-10-20-3D	FDA UDI	Class II	Active
Axium™ Detachable Coil System	QC-8-20-3D	FDA UDI	Class II	Active
Axium Prime Detachable Coil System	APB-6-15-3D-SS	FDA UDI	Class II	Active
Concerto Versa™	CV-7-40	FDA UDI	Class II	Active
Axium™ Detachable Coil System	PC-16-40-3D	FDA UDI	Class II	Active
Axium™ Detachable Coil System	QC-5-8-3D	FDA UDI	Class II	Active
Pipeline	FA-71425-30	FDA UDI	Class III	Active
HyperGlide	104-4113	FDA UDI	Class II	Active
Axium™ Prime Detachable Coil System	APB-2-3-HX-ES	FDA UDI	Class II	Active
Pipeline TM Flex Embolization Device with Shield Technology TM	PED2-325-25	FDA UDI	Class III	Active
Axium™ Prime Detachable Coil System	FC-3.5-10-3D	FDA UDI	Class II	Active
Axium™ Detachable Coil System	QC-14-30-HELIX	FDA UDI	Class II	Active
PipelineTM Vantage Embolization Device with Shield TechnologyTM	PED3-027-350-14	FDA UDI	Class III	Active
Axium Detachable Coil System	QC-25-50-3D	FDA UDI	Class II	Active
Axium™ Detachable Coil System	NC-2-1-HELIX	FDA UDI	Class II	Active
Cragg-McNamaraTM	41050-01	FDA UDI	Class II	Unknown
ConcertoTM	NV-4-10-HELIX	FDA UDI	Class II	Active
Pipeline	FA-77475-16	FDA UDI	Class III	Active
Pipeline	FA-71375-30	FDA UDI	Class III	Active
Pipeline	FA-77500-12	FDA UDI	Class III	Unknown
Concerto Detachable Coil System	PV-14-40-3D	FDA UDI	Class II	Active
HyperForm	104-4770	FDA UDI	Class II	Active
Pipeline	PED-375-14	FDA UDI	Class III	Active
Axium	PC-6-20-HELIX	FDA UDI	Class II	Active

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Micro Therapeutics, Inc. has nine FDA recall records initiated between July 13, 2021, and January 30, 2025. The records include both open and classified statuses, with reasons involving packaging exposure during transport, misalignment of product labeling (including size/configuration and international distribution discrepancies), and potential structural issues such as push wire fractures in delivery systems and embolization device malformations. The recalls address microcatheters, detachable coil systems, and embolization devices.

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
Jan 30, 2025	Z-1246-2025	—	open, classified	Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Jan 30, 2025	Z-1245-2025	—	open, classified	Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
Jan 11, 2024	Z-1253-2024	—	open, classified	European version of microcatheter were distributed within US which contain a different "Indications for Use".
Jan 11, 2024	Z-1252-2024	—	open, classified	European version of microcatheter were distributed within US which contain a different "Indications for Use".
Jun 30, 2022	Z-1557-2022	—	open, classified	Outer carton packaging of microcatheters were exposed to wet substance during transport.
Jun 30, 2022	Z-1556-2022	—	open, classified	Outer carton packaging of microcatheters were exposed to wet substance during transport.
Apr 27, 2022	Z-1261-2022	—	open, classified	Due to incorrect size and configuration labeling of the detachable coil system.
Jul 13, 2021	Z-2403-2021	—	open, classified	Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
Jul 13, 2021	Z-2402-2021	—	open, classified	Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.