FDAHealthJune 17, 2026
Medtronic Neurosurgery — 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 17, 2026
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.
What's affected?
- Product
- Ventriculostomy Kit, REF: 46154
- Lot code
- 2025-08779
Additional details
UDI-DI: 00673978947396, Lot: 2025-08779
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 167.
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