Cordis Neurovascular, Inc.
FDA adverse event reports naming Cordis Neurovascular, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CORDIS NEUROVASCULAR, INC..
- Total reports
- 3,388
- Deaths
- 121
- Injuries
- 1,109
- Malfunctions
- 2,150
Reports per year
Source: FDA adverse event reports by year received, 2002–2018. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Device, Neurovascular EmbolizationHCG1,629
- Intracranial Neurovascular StentNJE995
- Catheter, Continuous FlushKRA545
- Wire, Guide, CatheterDQX85
- Agent, Injectable, EmbolicMFE36
- Catheter, PercutaneousDQY34
- Catheter, Intravascular, DiagnosticDQO18
- Device, Vascular, For Promoting EmbolizationKRD15
- Tissue Adhesive For Use In Embolization Of Brain Arteriovenous MalformationsKGG13
- Clamp, UterineHGC7
Recent recalls
- 2006-09-02TerminatedOther
Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters.
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.
- 2006-09-02TerminatedOther
Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters.
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.
- 2003-10-15TerminatedOther
Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company.
These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
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