Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000019796 FEI 1000220862
- Devices
- 44
- Registrations
- EUDAMEDFDA
- FDA recalls
- 17
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Micro Therapeutics, Inc. d/b/a ev3 Neurovascular makes
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular manufactures neurovascular devices for cerebral revascularization and embolization, including aspiration systems, revascularization devices, micro catheters, guide catheters, and detachable coils. The Riptide Aspiration System is designed for clot removal during stroke treatment, while the Solitaire and Solitaire Platinum families provide thrombectomy solutions for acute ischemic stroke. Micro catheters like the Reverse 021 and Marathon Flow Directed are intended for targeted delivery in neurovascular procedures, and the Axium Prime and Axium Detachable Coil Systems are used for aneurysm embolization.
The company’s portfolio includes devices regulated as Class II and Class III under the FDA, with authorisations granted through 510(k) clearances and Premarket Approvals (PMA). Products are listed in the FDA’s 510(k) and PMA registries, reflecting compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 44 devicesCompany details
- EUDAMED SRN
- US-MF-000019796
- FDA FEI number
- 1000220862
- EUDAMED status
- Active since 2025
- EUDAMED registered name
- Micro Therapeutics Inc, d/b/a Ev3 Neurovascular
- Registered address
- 9775, Toledo Way, CA 92618, Irvine, United States
- [email protected]
- PRRC contact
- Amy Smith
FDA recalls
FDA recall records list 17 recalls initiated by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, the earliest on 2008-11-12 and the most recent on 2020-02-14. By recorded status: 17 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 2
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 14 Feb 2020 Z-1527-2020 Class I Terminated Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
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- 14 Feb 2020 Z-1528-2020 Class I Terminated Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
Full distribution text
- 14 Feb 2020 Z-1527-2020 Class I Terminated Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
2018
- 10 Aug 2018 Z-3022-2018 Class II Terminated The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.
- 26 Feb 2018 Z-1701-2018 Class I Terminated There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
2016
- 5 Oct 2016 Z-0307-2017 Class I Terminated Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
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- 5 Oct 2016 Z-0308-2017 Class I Terminated Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
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- 5 Oct 2016 Z-0309-2017 Class I Terminated Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
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- 5 Oct 2016 Z-0310-2017 Class I Terminated Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
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- 5 Oct 2016 Z-0307-2017 Class I Terminated Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
2015
- 4 Sep 2015 Z-0120-2016 Class II Terminated The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
2014
- 1 Apr 2014 Z-1453-2014 Class I Terminated Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
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- 1 Apr 2014 Z-1453-2014 Class I Terminated Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Show all 17 recalls
2014
- 1 Apr 2014 Z-1454-2014 Class I Terminated Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
Full distribution text
- 1 Apr 2014 Z-1454-2014 Class I Terminated Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
2013
- 19 Jul 2013 Z-2045-2013 Class II Terminated Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
2011
- 23 Sep 2011 Z-2471-2012 Class II Terminated The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
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- 23 Sep 2011 Z-2472-2012 Class II Terminated The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
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- 23 Sep 2011 Z-2471-2012 Class II Terminated The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
2010
- 1 Mar 2010 Z-0873-2012 Unclassified (pre-2012) Terminated ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
- 1 Mar 2010 Z-0874-2012 Unclassified (pre-2012) Terminated ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
2008
- 12 Nov 2008 Z-0841-2012 Unclassified (pre-2012) Terminated ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
Full distribution text
- 12 Nov 2008 Z-0841-2012 Unclassified (pre-2012) Terminated ev3 Neurovascular has identified an incorrect expiration date on the label of one lot of ev3 Axium coils Catalog QC-2-2-3D. This lot 5871057 shows an expiration date of 0211-04. The expiration date should read 2011-04. There are no functional issues with the coils in question as the appropriate expiration date is 2011.
Frequently asked questions
How many devices does Micro Therapeutics, Inc. d/b/a ev3 Neurovascular have in the registry?
The registry currently lists 44 devices for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micro Therapeutics, Inc. d/b/a ev3 Neurovascular's devices?
Among its 44 most recently registered devices, Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has devices listed in EUDAMED (3 devices), FDA 510(k) (40 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Micro Therapeutics, Inc. d/b/a ev3 Neurovascular's devices fall under?
Among its 44 most recently registered devices, the classes recorded for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular?
FDA recall records list 17 recalls initiated by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, the most recent initiated on 14 Feb 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular in the registry?
The most recently registered devices listed for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular include Cadence, 1 mL syringe, Onyx SCIFA and Riptide Aspiration System.