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Microvention Inc.

Active in EUDAMED
Also registered as Microvention

United Statesfrom SRN EUDAMED SRN US-MF-000016658

Microvention Inc. is a medical device manufacturer based in the United States, with 2,353 devices listed in 4 registries (FDA Class II, Class III and Unclassified; EU Class IIa) and 38 FDA recalls as of 13 Nov 2026.

Devices
2,353
Registrations
EUDAMED
FDA recalls
3811 ongoing

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 2,262
  • FDA 510(k) 86
  • EUDAMED 8
  • FDA PMA 4

A device listed in two registries counts in both.

Device classes
  • FDA Class II 2,119
  • FDA Class III 175
  • FDA Unclassified 57
  • EU Class IIa 2
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000016658
  • DUNS 003263105

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

What Microvention Inc. makes

Microvention Inc. manufactures neurovascular embolization coils, non-neurovascular embolization coils, bare-metal intracranial vascular stents, vascular microcatheters, vascular guide-catheters, cardiac/peripheral vascular guidewires, embolization particles, and adenovirus immunoglobulin A (IgA) antibody IVD calibrators.

The company's portfolio includes Class II, Class III, and unclassified devices listed in the FDA UDI registry, and it is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2,353

Newest first, rows 1-50 of 2,353

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Rows 1-50 of 2,353

Showing 1-50 of 2,353

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000016658
DUNS number
003263105
EUDAMED status
Active
EUDAMED registered name
Microvention Inc.
EUDAMED abbreviated name
MVI
Registered address
35, Enterprise, 92656, Aliso Viejo, United States
Phone
+1.714.247.8000
PRRC contact
Scafford Serron(public in EUDAMED)

FDA recalls38

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 38 recalls initiated by MICROVENTION INC., the earliest on 2017-08-07 and the most recent on 2026-04-30. By recorded status: 11 ongoing and 27 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, 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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 22
  • 2020 0
  • 2021 4
  • 2022 1
  • 2023 3
  • 2024 3
  • 2025 2
  • 2026 2

Showing the 10 most recent of 38 recalls.

  • 2026

    • 30 Apr 2026 Z-2912-2026 Class II Ongoing Due to an increase rate of balloon pinhole defects. Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT,…
      Full distribution text Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countries of Europe - Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Ukraine, and United Kingdom. Asia - China, Japan, Jordan, New Zealand, South Korea, and United Arab Emirates.
      Submission number: K193607
    • 6 Apr 2026 Z-2200-2026 Class II Ongoing 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, ischemic neurological events Distribution: International distribution to the country of China. Submission number: P170013

  • 2025

    • 5 Sep 2025 Z-0108-2026 Class II Ongoing 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 health consequences. Distribution: Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL,…
      Full distribution text Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, KR, SK, MX, DK, IR, SA, BY, PA, VN, ZA, BR, TW, CN, BE, FR, VE, MY.
      Submission numbers: P180027, P180027S002
    • 29 May 2025 Z-2188-2025 Class II Ongoing 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 patient. Distribution: OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia,…
      Full distribution text OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile, Hong Kong , India, Mexico, Taiwan, Vietnam
      Submission number: K150958

  • 2024

    • 11 Dec 2024 Z-1121-2025 Class II Ongoing Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer. Distribution: US: None OUS: China Submission number: P170013
    • 2 Dec 2024 Z-0990-2025 Class II Ongoing Sterility assurance; microcatheter inner packaging may contain incomplete seal. Distribution: US: None OUS: China Submission number: K101542
    • 5 Aug 2024 Z-3157-2024 Class II Ongoing 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. Distribution: U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA. Submission number: K211120

  • 2023

    • 21 Dec 2023 Z-0868-2024 Class II Ongoing Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. Distribution: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI. Submission numbers: K150870, K192684
    • 24 Aug 2023 Z-0187-2024 Class II Ongoing Peripheral coil system detachable has a potential of unsealed pouch packaging. Distribution: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA. Submission number: K151358
    • 7 Jun 2023 Z-2238-2023 Class II Ongoing Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended. Distribution: Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS and the countries of Taiwan, Chile, India, South Korea, Malaysia, Canada, France, Morocco, Belgium, Spain, Turkey, Poland, Russian Federation, Czech Republic, Slovenia, Germany, United Kingdom, El Salvador, United Arab Emirates, Bulgaria, Portugal, Brazil, Iran, Malta, Vietnam, South Africa, Jordan, Japan, Uruguay.
Show the 25 most recent of 38 recalls

  • 2022

    • 21 Sep 2022 Z-0170-2023 Class II Ongoing 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 cause the implant to move and damage vessels Distribution: Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN,…
      Full distribution text Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Australia, South Korea, Italy, UK.
      Submission number: P170032

  • 2021

    • 20 Oct 2021 Z-0202-2022 Class II Terminated Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers. Distribution: US Nationwide distribution in the states of AL, NY, NV. Submission number: K994253
    • 21 Apr 2021 Z-1828-2021 Class III Terminated Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. Distribution: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. Submission number: K192135
    • 21 Apr 2021 Z-1829-2021 Class III Terminated Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. Distribution: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. Submission number: K192135
    • 21 Apr 2021 Z-1830-2021 Class III Terminated Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. Distribution: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. Submission number: K192135

  • 2019

    • 24 Nov 2019 Z-1220-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K120630
    • 24 Nov 2019 Z-1221-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K120630
    • 24 Nov 2019 Z-1222-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K120630
    • 24 Nov 2019 Z-1223-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K151358
    • 24 Nov 2019 Z-1224-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K151358
    • 24 Nov 2019 Z-1225-2020 Class II Terminated The devices may be missing the implant coil. Distribution: The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was…
      Full distribution text The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
      Submission number: K151358
    • 22 Nov 2019 Z-1392-2020 Class II Terminated The devices may be missing the implant coil. Distribution: All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil,…
      Full distribution text All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
      Submission numbers: K050954, K132952, K153594, K161367, K091641
    • 22 Nov 2019 Z-1393-2020 Class II Terminated The devices may be missing the implant coil. Distribution: All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil,…
      Full distribution text All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
      Submission numbers: K050954, K132317, K132952, K153594, K161452, K091641
    • 22 Nov 2019 Z-1394-2020 Class II Terminated The devices may be missing the implant coil. Distribution: All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil,…
      Full distribution text All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
      Submission numbers: K050954, K131948, K132952, K153594
    • 22 Nov 2019 Z-1395-2020 Class II Terminated The devices may be missing the implant coil. Distribution: All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil,…
      Full distribution text All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
      Submission numbers: K050954, K131948, K132952, K153594, K091641

Frequently asked questions

How many devices does MICROVENTION INC. have in the registry?

The registry currently lists 2353 devices for MICROVENTION INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MICROVENTION INC.'s devices?

Among its 50 most recently registered devices, MICROVENTION INC. has devices listed in EUDAMED (3 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do MICROVENTION INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for MICROVENTION INC.'s devices are Class IIa, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for MICROVENTION INC.?

FDA recall records list 38 recalls initiated by MICROVENTION INC., the most recent initiated on 30 Apr 2026. 11 of them are recorded as ongoing. 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 MICROVENTION INC. in the registry?

The most recently registered devices listed for MICROVENTION INC. include MV Flow ™ Aspiration Pump, WEB™ Detachment Controller, MV Flow Aspiration Pump MVFLOWPMP01-US and WEB Detachment Controller WDC-2-MVI-AL.

Generated automatically from registry data and not verified by a human reviewer.