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Cook Vascular, Inc.

United StatesFDA applicant, unverified

Devices
12
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cook Vascular, Inc. makes

Cook Vascular, Inc. manufactures vascular access and interventional cardiology devices, including coronary sinus introducer systems, mechanical dilator sheaths for vessel preparation, electrosurgical dissection sheaths, and Doppler-based flow monitoring tools. Their product line also covers hemostasis valves, power injectable infusion sets and ports, and tissue stabilization sheaths designed for procedural support in cardiac and vascular interventions.

The company’s devices are classified under Class II in the US and are listed via the FDA’s 510(k) pathway. Their products are intended for use in diagnostic and interventional cardiology procedures, with regulatory compliance managed through the US Food and Drug Administration’s premarket notification process.

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

Catalogue12

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Rows 1-12 of 12

FDA recalls6

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

FDA recall records list 6 recalls initiated by Cook Vascular, Inc., the earliest on 2007-12-17 and the most recent on 2017-11-28. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

5 initiated before 2017

  • 2017

    • 28 Nov 2017 Z-1223-2018 Class II Terminated Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall. Distribution: The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina,…
      Full distribution text The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.
      Submission number: K081425

  • 2008

    • 24 Apr 2008 Z-2190-2008 Unclassified (pre-2012) Terminated Mislabeled - wrong size catheter was packaged in the box Distribution: The products were shipped to distributors in Japan and Brazil. Submission number: K924748
    • 24 Apr 2008 Z-2191-2008 Unclassified (pre-2012) Terminated mislabeled - wrong size catheter was packaged in the box Distribution: The products were shipped to distributors in Japan and Brazil. Submission number: K924748
    • 2 Mar 2008 Z-2176-2008 Unclassified (pre-2012) Terminated mislabeled - 300 micron flexipets labeled as 130 micron and vice versa Distribution: The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI. Submission number: K983596
    • 2 Mar 2008 Z-2177-2008 Unclassified (pre-2012) Terminated mislabeled - 300 micron flexipets labeled as 130 micron and vice versa Distribution: The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI. Submission number: K983596

  • 2007

    • 17 Dec 2007 Z-2178-2008 Unclassified (pre-2012) Terminated mislabeled - 300 micron flexipets were labeled as 80 microns Distribution: The product was shipped to a medical facility in TN and sales reps in NJ and MD. The product was also shipped to…
      Full distribution text The product was shipped to a medical facility in TN and sales reps in NJ and MD. The product was also shipped to distributors in Indonesia, Australia, and Ireland
      Submission number: K983596

Frequently asked questions

How many devices does Cook Vascular, Inc. have in the registry?

The registry currently lists 12 devices for Cook Vascular, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cook Vascular, Inc.'s devices?

Among its 12 most recently registered devices, Cook Vascular, Inc. has devices listed in FDA 510(k) (12 devices).

What risk classes do Cook Vascular, Inc.'s devices fall under?

Among its 12 most recently registered devices, the classes recorded for Cook Vascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cook Vascular, Inc.?

FDA recall records list 6 recalls initiated by Cook Vascular, Inc., the most recent initiated on 28 Nov 2017. 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 Cook Vascular, Inc. in the registry?

The most recently registered devices listed for Cook Vascular, Inc. include COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM, EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0, COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH and Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath.

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