# FDA recall Z-2768-2026

> **Medtronic Neurosurgery** · Class II · device recall initiated 2026-06-17.

## Product

Ventriculostomy Kit, REF: 46154

## Reason for recall

Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.

## Distribution

Worldwide - US Nationwide distribution in the states of UT, AL, CA, NC, GA, AR, LA, KY, LA, KY, IL, OK and the country of Costa Rica.

## Key facts

- **Recall number:** Z-2768-2026
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-17
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Haltom City, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2768-2026

## Citation

> AI Analytics. FDA recall Z-2768-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2768-2026. Source: US FDA. Licensed CC0.

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