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Medtronic Neurosurgery: Ventriculostomy Kit, REF: 46154

Medical DevicesSource: FDA (device) · Date: 2026-07-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Neurosurgery
Product
Ventriculostomy Kit, REF: 46154
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-06-17
Code info
UDI-DI: 00673978947396, Lot: 2025-08779
Product quantity
167
Voluntary mandated
Voluntary: Firm initiated
City
Haltom City
State
TX
Country
United States
Event id
99342
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