Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2791-2018

May 31, 2018

Class II

Product summary

Firm
Cook Inc.
Event
Event 80492
Status
Terminated
Classification
Class II
Quantity
250
Official record key
device-enforcement:Z-2791-2018

Official wording

Reason: 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).

Code information: lot 8639185

Distribution pattern: One distributor in Indiana; product was not further distributed to end users.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).