FDA Device recall Z-2791-2018
VentriClear Ventricular Drainage Catheter Set, Cat
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of VentriClear Ventricular Drainage Catheter Set, Cat by Cook, citing this lot of VentriClear failed endotoxin testing. Potential adverse events include immune responses ranging from non-specific febrile reaction to life-threatening systemic inflamm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2791-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-31 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | IN |
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.
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).
Identifiers
| code_info | lot 8639185 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2791-2018%22
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