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Cordis Neurovascular, Inc.

Also registered as Cordis Neurovascular

United StatesFDA applicant, unverified

Devices
38
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cordis Neurovascular, Inc. makes

Cordis Neurovascular, Inc. manufactures neurovascular devices including infusion catheters (such as the PROWLER SELECT, PROWLER PLUS, TRANSIT, and FG models), guiding catheters (e.g., ENVOY and 5F ENVOY), steerable guidewires (e.g., ESSENCE and AGILITY), and detachable coil systems (TRUFILL DCS and TRUFILL DCS Orbit). The portfolio also includes coil system line extensions and infusion-specific syringes like the TRUFILL DCS.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The manufacturer is based in the United States.

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

Catalogue38

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FDA recalls3

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

FDA recall records list 3 recalls initiated by Cordis Neurovascular, Inc., the earliest on 2001-10-19 and the most recent on 2006-08-11. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination 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.

  • 2006

    • 11 Aug 2006 Z-1482-06 Unclassified (pre-2012) Terminated Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch. Distribution: Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada,…
      Full distribution text Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
      Submission number: K021591
    • 11 Aug 2006 Z-1483-06 Unclassified (pre-2012) Terminated Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch. Distribution: Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada,…
      Full distribution text Class II Recall - Worldwide distribution --- including USA and countries of Asia Pacific, Europe, Latin America, Canada, Japan and Australia.
      Submission number: K021591

  • 2001

    • 19 Oct 2001 Z-0018-04 Unclassified (pre-2012) Terminated These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray. Distribution: Product was distributed to 4 US hospital accounts and to one Distirbutor in Japan. Submission number: K003925

Frequently asked questions

How many devices does Cordis Neurovascular, Inc. have in the registry?

The registry currently lists 38 devices for Cordis Neurovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cordis Neurovascular, Inc.'s devices?

Among its 38 most recently registered devices, Cordis Neurovascular, Inc. has devices listed in FDA 510(k) (38 devices).

What risk classes do Cordis Neurovascular, Inc.'s devices fall under?

Among its 38 most recently registered devices, the classes recorded for Cordis Neurovascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cordis Neurovascular, Inc.?

FDA recall records list 3 recalls initiated by Cordis Neurovascular, Inc., the most recent initiated on 11 Aug 2006. 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 Cordis Neurovascular, Inc. in the registry?

The most recently registered devices listed for Cordis Neurovascular, Inc. include PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS, TRUFILL DCS SYRINGE, ESSENCE GUIDEWIRE and AGILITY STEERABLE GUIDEWIRE.

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