Medtronic Neurosurgery Ventriculostomy Kit recalled for excess endotoxin levels
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.
From the FDA notice · Read the official notice ↗ · All Medtronic recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Ventriculostomy Kit, REF: 46154
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 167
- Illnesses reported
- None reported
- Manufactured in
- 4620 N Beach St, N/A, Haltom City, TX, United States
- Classification
- Class II
- Recall number
- Z-2768-2026
In the FDA's words
- Description
- Ventriculostomy Kit, REF: 46154 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. UDI-DI: 00673978947396, Lot: 2025-08779 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. Affected quantity: 167
- 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.