Ventriculostomy Kit, REF: 46154
Medtronic Neurosurgery
The 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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Ventriculostomy Kit, REF: 46154
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 00673978947396Model Lot: 2025-08779UPC 00673978947396Would you have heard about this one?
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