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Stryker Neurovascular

Active in EUDAMED
Also registered as Stryker Neurovscular

United Statesfrom SRN EUDAMED FDA SRN US-MF-000002456 FEI 3012931345

Devices
70
Registrations
EUDAMEDFDA
FDA recalls
10915 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

8 of 8 in force.

See certificates

Market reach

European Union
EUDAMED actor, 8 certificates
United States
FDA establishment, FDA recalls

Catalogue70

Newest first, rows 1-50 of 70

Search and filter all 70 devices
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  • Wingspan Ref WE025015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 6 Ref IC060132A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE030015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E0815

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 5 Ref IC058132A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 7 Ref IC068132A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E0611

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 7 Ref IC068125A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E1018

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E1221

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 5 Ref IC058115A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Infinity LS Ref GEN-10476-80

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE045009

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE035015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE035020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE045020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Catalyst 7 Ref IC068115A

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Infinity LS Ref GEN-10476-90

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Offset Ref DC050150

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E0916

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE025020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE045015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE030020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE040009

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE040020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE040015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE035009

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • AXS Infinity LS Ref GEN-10476-70

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE025009

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Wingspan Ref WE030009

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trevo Trak 21 Microcatheter Ref K261889

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Xtra Detachable Coil Ref K261772

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Excelsior Reach Microcatheter Ref K261649

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Trenza Ref IST00E0713

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Trenza Ref IST00E1119

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter Ref K242289

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AXS Lift Intracranial Base Catheter Ref K243593

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AXS Offset Delivery Assist Catheter Ref K163259

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AXS Vecta Aspiration System Ref K191768

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Detachable Coils Ref K161429

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Detachable Coil Ref K120850

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Detachable Coil Ref K123377

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Detachable Coil Ref K113412

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Broadway 8 Catheter Ref K241768

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • InZone Detachment System Ref K212455 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Tetra Detachable Coils Ref K222533

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Target Detachable Coils Ref K153658

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Transgate Guide Catheter Ref K132542

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter Ref K200206

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Traget Detachable Coil Ref K112385

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 70

Showing 1-50 of 70

Company details

EUDAMED SRN
US-MF-000002456
FDA FEI number
3012931345
EU VAT number
IE9771305F
EUDAMED status
Active
EUDAMED registered name
Stryker Neurovascular
EUDAMED abbreviated name
SNV
Registered address
47900, Bayside Parkway, 94538, Fremont, United States
Phone
+1 510 413 2500
PRRC contact
Tara Lopez(public in EUDAMED)

EUDAMED certificates8

8 certificates8 valid, 0 expiredMDR 8next expiry 16 Nov 2026

EUDAMED certificates (8)

BSI Group The Netherlands B.V. 2797 8 certificates

  • MDR 728401 Active Reissued

    Quality management system EU MDR

    Issued
    18 Sep 2026
    Expires
    16 Nov 2031
    Valid from
    17 Nov 2026
  • MDR 829526 Active

    Technical documentation EU MDR

    Issued
    25 Jun 2026
    Expires
    24 Jun 2031
  • MDR 739951 Active Amended

    Technical documentation EU MDR

    Issued
    27 Feb 2024
    Expires
    23 May 2028
    Reason
    Other
  • MDR 736172 Active

    Technical documentation EU MDR

    Issued
    2 Mar 2023
    Expires
    1 Mar 2028
  • MDR 736166 Expiring Expires in 349 days

    Technical documentation EU MDR

    Issued
    15 Oct 2022
    Expires
    14 Oct 2027
  • MDR 736168 Expiring Supplemented Expires in 349 days

    Technical documentation EU MDR

    Issued
    23 Dec 2023
    Expires
    14 Oct 2027
    Reason
    Other
  • MDR 737645 Expiring Expires in 349 days

    Technical documentation EU MDR

    Issued
    15 Oct 2022
    Expires
    14 Oct 2027
  • MDR 728401 Expiring Supplemented Expires in 17 days

    Quality management system EU MDR

    Issued
    25 Jun 2026
    Expires
    16 Nov 2026
    Reason
    Add device or group

FDA recalls109

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 8
  • 2018 12
  • 2019 3
  • 2020 1
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 13
  • 2025 0
  • 2026 1

70 initiated before 2017

Showing the 10 most recent of 109 recalls.

  • 2026

    • 6 Apr 2026 Z-2552-2026 Class II Ongoing Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.via FDA establishment Stryker Neurovascular Distribution: Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.
      Submission number: K212455

  • 2024

    • 30 Aug 2024 Z-0021-2025 Class II Ongoing Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. Distribution: U.S. Nationwide distribution in the states of CA and VA. Submission number: K211594
    • 23 Apr 2024 Z-1902-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K173352
    • 23 Apr 2024 Z-1903-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K133464
    • 23 Apr 2024 Z-1904-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission numbers: K131437, K113260
    • 23 Apr 2024 Z-1905-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K223305
    • 23 Apr 2024 Z-1906-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K211594
    • 23 Apr 2024 Z-1907-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K153729
    • 23 Apr 2024 Z-1908-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission number: K133177
    • 23 Apr 2024 Z-1909-2024 Class II Ongoing Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. Distribution: Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MN, PA, IL, AK, NY, CA, MI, WI, TX, AZ, FL, KY, MA, IN, NE, MT, CT, NJ, TN, VA, AL, CO, DE, OH, UT, NC, ME, GA, SC, GU, WA, MO, OR, DC, OK, LA, MD, ID, NH, SD, NV, RI, ND, HI, MS, AR, IA, NM, VT, KS and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, SAR China, Hungary, India, Ireland, Israel, Italy, Japan, Korea (South), Lithuania, Luxembourg, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Republic of China, Thailand, Turkey, United Arab Emirates, United Kingdom.
      Submission numbers: K023700, K002907
Show the 25 most recent of 109 recalls

  • 2024

    • 18 Apr 2024 Z-1939-2024 Class II Ongoing Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique. Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.
      Submission number: K032146
    • 18 Apr 2024 Z-1940-2024 Class II Ongoing Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique. Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.
      Submission number: K202522
    • 18 Apr 2024 Z-1941-2024 Class II Ongoing Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique. Distribution: Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.
      Submission number: K053268
    • 3 Apr 2024 Z-1740-2024 Class II Ongoing Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. Distribution: US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL. Submission number: K133177

  • 2022

    • 3 Jun 2022 Z-1386-2022 Class II Ongoing Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of CA, OR, PA, NY, DC, IL, WA, NH, NJ, OK, FL, AZ, AL, GA, TX, WI, VA and the countries of DE, IT, AT.
      Submission number: K192122

  • 2020

    • 21 Sep 2020 Z-0114-2021 Class I Terminated Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature. Distribution: U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN,…
      Full distribution text U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Estonia, Lithuania, Slovenia, Australia, Finland, Luxembourg, South Africa, Austria, France, Mexico, South Korea, Belgium, Germany, Netherlands, Spain, Brazil, Greece, Norway, Sweden, Canada, Hong Kong, Philippines, Switzerland, Chile, Hungary, Poland, Taiwan, Colombia, India, Portugal, Thailand, Croatia, Ireland, Romania, Turkey, Czech Republic, Israel, Saudi Arabia, United Arab Emirates, Denmark, Italy, Singapore, United Kingdom, Egypt, Japan, Slovakia, Vietnam
      Submission number: K190779

  • 2019

    • 18 Apr 2019 Z-1708-2019 Class II Terminated A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft. Distribution: U.S Nationwide Distribution - PA, VA, TX, CA, FL, AR, TN, MI, NY, IL, NC, KY, WV, OH, MO, AZ, GA, WA, VT, DC, SC, NJ,…
      Full distribution text U.S Nationwide Distribution - PA, VA, TX, CA, FL, AR, TN, MI, NY, IL, NC, KY, WV, OH, MO, AZ, GA, WA, VT, DC, SC, NJ, MN, OK, MD, AL, LA, MA, DE, IN, OR, RI, SD, MS, WI, ID, UT, CO, IA, KS, CT, NE, NM
      Submission number: K172468
    • 10 Apr 2019 Z-1620-2020 Class II Terminated The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use. Distribution: US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY,…
      Full distribution text US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY, SC, TX, AL, VA, UT, MD, GA, LA, CO, WA, KY, OK, RI, SD, MS, NE,IA, KS, DC. No US Govt. No Foreign countries.
      Submission number: K172167
    • 10 Apr 2019 Z-1621-2020 Class II Terminated The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use. Distribution: US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY,…
      Full distribution text US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY, SC, TX, AL, VA, UT, MD, GA, LA, CO, WA, KY, OK, RI, SD, MS, NE,IA, KS, DC. No US Govt. No Foreign countries.
      Submission number: K181354

  • 2018

    • 13 Nov 2018 Z-0065-2020 Class II Terminated Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging Distribution: OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland,…
      Full distribution text OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland
      Submission numbers: K112404, K010954
    • 8 Jun 2018 Z-0225-2020 Class II Terminated The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL,…
      Full distribution text Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
      Submission number: K190843
    • 8 Jun 2018 Z-0226-2020 Class II Terminated The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL,…
      Full distribution text Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
      Submission number: K190843
    • 8 Jun 2018 Z-0227-2020 Class II Terminated — Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL,…
      Full distribution text Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
      Submission number: K190843
    • 8 Jun 2018 Z-0228-2020 Class II Terminated The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL,…
      Full distribution text Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
      Submission number: K190843
    • 8 Jun 2018 Z-0229-2020 Class II Terminated The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. Distribution: Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL,…
      Full distribution text Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
      Submission number: K190843

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Stryker Neurovascular Cork Munster · IE FEI 3008881809

Frequently asked questions

How many devices does Stryker Neurovascular have in the registry?

The registry currently lists 70 devices for Stryker Neurovascular. Devices recorded under merged duplicate company entries are counted once.

Which registries list Stryker Neurovascular's devices?

Among its 50 most recently registered devices, Stryker Neurovascular has devices listed in EUDAMED (32 devices) and FDA 510(k) (18 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Stryker Neurovascular's devices fall under?

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

Are there FDA recall records for Stryker Neurovascular?

FDA recall records list 109 recalls initiated by Stryker Neurovascular, the most recent initiated on 6 Apr 2026. 15 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 EUDAMED certificates are recorded for Stryker Neurovascular?

EUDAMED lists 8 certificates for Stryker Neurovascular (quality management system; technical documentation) under MDR. 4 are recorded with the status issued. The most recent was issued on 18 Sep 2026.

What are the newest devices from Stryker Neurovascular in the registry?

The most recently registered devices listed for Stryker Neurovascular include Wingspan, AXS Catalyst 6, Trenza and AXS Catalyst 5.

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