# FDA recall Z-2791-2018

> **Cook Inc.** · Class II · device recall initiated 2018-05-31.

## 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 for recall

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).

## Distribution

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

## Key facts

- **Recall number:** Z-2791-2018
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-31
- **Report date:** 2018-08-22
- **Termination date:** 2019-04-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2791-2018

## Citation

> AI Analytics. FDA recall Z-2791-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2791-2018. Source: US FDA. Licensed CC0.

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