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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 1 of 63

Device	Model / Reference	Registries	Class	Status
Pipeline	PED-325-16	FDA UDI	Class III	Active
Pipeline	PED-500-10	FDA UDI	Class III	Active
X-celeratorTM	103-0602-300	FDA UDI	Class II	Active
Axium	PC-16-40-3D	FDA UDI	Class II	Active
Concerto Detachable Coil System	NV-7-20-HELIX	FDA UDI	Class II	Unknown
Axium	QC-3.5-12-3D	FDA UDI	Class II	Active
Axium Prime	APB-4-12-3D-SS	FDA UDI	Class II	Active
Axium	PC-6-10-3D	FDA UDI	Class II	Active
AxiumTM	APB-1-2-3D-ES	FDA UDI	Class II	Active
Axium	NC-4-10-HELIX	FDA UDI	Class II	Active
Axium	QC-12-30-HELIX	FDA UDI	Class II	Active
HyperGlideTM	104-4520	FDA UDI	Class II	Active
Axium™ Detachable Coil System	PC-7-30-HELIX	FDA UDI	Class II	Active
Cragg-McNamara	41032-01	FDA UDI	Class II	Active
Pipeline TM Flex Embolization Device with Shield Technology TM	PED2-425-10	FDA UDI	Class III	Active
Axium™ Detachable Coil System	NC-2-2-HELIX	FDA UDI	Class II	Active
Pipeline	PED-450-30	FDA UDI	Class III	Active
Axium™ Prime Detachable Coil System	APB-2.5-4-HX-ES	FDA UDI	Class II	Active
AxiumTM	APB-3.5-6-3D-ES	FDA UDI	Class II	Active
AxiumTM	QC-14-30-3D	FDA UDI	Class II	Active
Pipeline	FA-71350-35	FDA UDI	Class III	Active
Axium Detachable Coil System	QC-2-6-3D	FDA UDI	Class II	Active
MarathonTM	105-5055	FDA UDI	Class II	Active
Axium™ Detachable Coil System	PC-3-8-HELIX	FDA UDI	Class II	Active
ConcertoTM	PV-8-20-3D	FDA UDI	Class II	Active
Pipeline	FA-71450-25	FDA UDI	Class III	Active
Axium PrimeTM	FC-4-12-3D	FDA UDI	Class II	Active
AxiumTM	QC-2.5-6-HELIX	FDA UDI	Class II	Active
Rebar	105-5080-153C	FDA UDI	Class II	Active
X-Pedion	103-0605-200	FDA UDI	Class II	Active
ConcertoTM	PV-4-8-3D	FDA UDI	Class II	Active
Axium	QC-9-30-HELIX	FDA UDI	Class II	Active
Pipeline	FA-77300-16	FDA UDI	Class III	Active
PipelineTM Flex Embolization Device with Shield TechnologyTM	PED2-425-14	FDA UDI	Class III	Active
AxiumTM	QC-4-12-HELIX	FDA UDI	Class II	Active
Solitaire™ X-PACK	XPACK204	FDA UDI	Class II	Active
Nxt	N-3-12-T10	FDA UDI	Class II	Active
PipelineTM Vantage Embolization Device with Shield TechnologyTM	PED3-021-350-10	FDA UDI	Class III	Active
Axium™ Detachable Coil System	PC-2-1-HELIX	FDA UDI	Class II	Active
AxiumTM	PC-2-6-HELIX	FDA UDI	Class II	Active
Concerto Detachable Coil System	PV-7-30-3D	FDA UDI	Class II	Active
ConcertoTM	PV-2-6-3D	FDA UDI	Class II	Active
AxiumTM	APB-2-4-3D-ES	FDA UDI	Class II	Active
Pipeline	FA-77500-18	FDA UDI	Class III	Active
Axium Detachable Coil System	QC-4-8-3D	FDA UDI	Class II	Active
Axium PrimeTM	FC-5-15-3D	FDA UDI	Class II	Active
Pipeline	FA-77425-10	FDA UDI	Class III	Active
Pipeline TM Flex Embolization Device with Shield Technology TM	PED2-350-14	FDA UDI	Class III	Active
Marksman	FA-55150-1030	FDA UDI	Class II	Active
ConcertoTM	PV-2-6-3D	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.