FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medtronic Neurosurgery Ventriculostomy Kit recalled for excess endotoxin levels

OTHERNationwide distributionMedical devices

What this means

Medtronic Neurosurgery's Ventriculostomy Kit (REF: 46154) may contain endotoxin levels higher than safe limits for devices that contact cerebrospinal fluid during brain surgery. Endotoxin exposure can trigger acute inflammation in the brain and nervous system.

If your hospital or clinic received this kit (Lot 2025-08779, UDI-DI 00673978947396), do not use it.
Contact Medtronic immediately for instructions on return or replacement.
Review patient records if the kit was already used and monitor patients for signs of inflammation or neurological changes.

The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

167

Manufactured in

4620 N Beach St, N/A, Haltom City, TX, United States

Products

Ventriculostomy Kit, REF: 46154

Official notice

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

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