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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 63 of 63

Device	Model / Reference	Registries	Class	Status
Nexus Detachable Coil System, Morpheus 3d Csr	K060625	FDA 510(k)	Class II	Active
Silverspeed Hydrophilic Guidewire, Models 103-0601-300 And 103-0602-300	K010497	FDA 510(k)	Class II	Active
Echelon Micro Catheter	K051990	FDA 510(k)	Class II	Active
Silverstreak Hydrophilic Guidewire	K982543	FDA 510(k)	Class II	Active
Titan Micro Catheter, Model 105-5074-153; Hd Injector, Model 103-0305	K022003	FDA 510(k)	Class II	Active
Ultraflow Hpc Flow Directed Micro Catheter, Models 105-5065 And 105-5066	K024118	FDA 510(k)	Class II	Active
Nautica Micro Catheter, Model 105-5094-153	K024122	FDA 510(k)	Class II	Active
14 Wire Standard, 14 Wire Ls	K113454	FDA 510(k)	Class II	Active
Nexus Detachable Coil, Multi-Diameter Csr And Helix Super Soft Csr	K051560	FDA 510(k)	Class II	Active
Marathon Flow Directed Micro Catheter, Model 105-5055	K034036	FDA 510(k)	Class II	Active
Flow Rider Flow Directed Micro Catheter	K980104	FDA 510(k)	Class II	Active
Equinox Occlusion Balloon System	K990487	FDA 510(k)	Class II	Active
Mti 1 Ml Syringe	K991225	FDA 510(k)	Class II	Active
Sapphire Detachable Coil System	K030392	FDA 510(k)	Class II	Active
Hyperglide Occlusion Balloon System, Model 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123	K011526	FDA 510(k)	Class II	Active
Echelon 10, 45 Tip Shape Micro Catheter Echelon 10, 90 Tip Shape Micro Catheter, Echelon 14, 45 Tip Shape Micro Catheter, 90	K042187	FDA 510(k)	Class II	Active
Cadence Precision Injector, Model 103-0304	K011535	FDA 510(k)	Class II	Active
Micro Therapeutics Variable Infusion Length Catheter	K953335	FDA 510(k)	Class II	Active
Sapphire Detachable Fiber Coils	K031852	FDA 510(k)	Class II	Active
Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models	K033372	FDA 510(k)	Class II	Active
Echelon Micro Catheter, Model 105-5091	K031992	FDA 510(k)	Class II	Active
Nexus Detachable Coil System	K050543	FDA 510(k)	Class II	Active
2.9f Cragg-Mcnamara Valved Infusion Catheter	K964868	FDA 510(k)	Class II	Active
.010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic Guidewire, .016 Silverspeed Hydrophilic Guidewi	K993257	FDA 510(k)	Class II	Active
Micro Therapeutics Infusion Catheter	K940634	FDA 510(k)	Class II	Active
Truline Reinforced Valved Infusion Catheter	K021139	FDA 510(k)	Class II	Active
Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026	K010162	FDA 510(k)	Class II	Active
Rebar Micro Catheter: Rebar-10 (1.7f), 153 Cm, Dual Marker Bands; Rebar Micro Catheter: Rebar-10 (1.7f), 170 Cm, Dual Ma	K002723	FDA 510(k)	Class II	Active
Fx Detachable Coil System	K060747	FDA 510(k)	Class II	Active
Sapphire Nxt Detachable Coil System	K041649	FDA 510(k)	Class II	Active
Micro Therapeutics Sidehole Infusion Wire	K954020	FDA 510(k)	Class II	Active
Sapphire Vds Tension Safe Detachable Coil, E-3-12/3-T10-Vt	K032497	FDA 510(k)	Class II	Active
Axium Detachable Coil System	K081465	FDA 510(k)	Class II	Active
Orion Micro Catheter	K113289	FDA 510(k)	Class II	Active
Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771	K011656	FDA 510(k)	Class II	Active
Concerto Detachable Coil System	K090046	FDA 510(k)FDA UDI	Class II	Active
Modification To Hyperglide Occlusion Balloon System	K021066	FDA 510(k)	Class II	Active
Flowrider Flow Directed Micro Catheter, Model 105-5065	K010004	FDA 510(k)	Class II	Active
Rebar Micro Catheter: Rebar-18 [2.3f], 110 Cm, 130 Cm, 153 Cm, Single Marker Band And 153 Cm, Dual Marker Band	K001966	FDA 510(k)	Class II	Active
Rebar Micro Catheter, Models 105-5080, 105-5086	K993672	FDA 510(k)	Class II	Active
Thrombolytic Brush Catheter	K963925	FDA 510(k)	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.