Medtronic Neurosurgery Ventriculostomy Kit recalled for excess endotoxin levels
Medtronic Ventriculostomy Kit recalled for endotoxin contamination
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.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2768-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief