Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VentriClear Ventricular Drainage Catheter Set Recalled by Cook Inc. Due to This lot of VentriClear failed endotoxin testing. Potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.
Affected Products
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.
Quantity: 250
Why Was This Recalled?
This lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflammatory response syndrome (SIRS).
Where Was This Sold?
One distributor in Indiana; product was not further distributed to end users.
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report