Class II — Medtronic Neurosurgery
| Recalling firm | Medtronic Neurosurgery |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Ventriculostomy Kit, REF: 46154 |
| Quantity | 167 |
| 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. |
| Initiated | 2026-06-17 |
| Classified | 2026-07-21 |
| Recall number | Z-2768-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Neurosurgery (Z-2768-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99342/
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