Ventriculostomy Kit recall (Medtronic Neurosurgery)
Medical deviceClass IIOngoing
Summary: Medtronic Neurosurgery is recalling Ventriculostomy Kit, REF: 46154. Reason: 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.
What is being recalled
Ventriculostomy Kit, REF: 46154
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arkansas, California, Georgia, Illinois, Kentucky, Louisiana, North Carolina, Oklahoma, Utah)
How to tell if yours is affected
UDI-DI: 00673978947396, Lot: 2025-08779
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2768-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 17, 2026 |
| Reported | July 29, 2026 |
| Company | Medtronic Neurosurgery |
| Company location | Haltom City, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 167 |
More recalls from Medtronic Neurosurgery · all medical device recalls · recalls from June 2026