The Recall Desk
HighFDA (Devices)·Z-2768-2026·Announced 2026-07-29

Medtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels

Medtronic Neurosurgery is recalling Ventriculostomy Kit (REF: 46154) because endotoxin levels may exceed acceptable limits for devices contacting cerebrospinal fluid.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen/contaminant (endotoxin) in a device used for contact with cerebrospinal fluid, representing a risk-of-harm where injury has not yet been reported.

Plain-English summary

Medtronic Neurosurgery is recalling Ventriculostomy Kit, REF: 46154, due to potential endotoxin contamination. These devices are used during ventriculostomy procedures to gain access to the ventricular system.

Endotoxin levels in these kits may exceed the acceptable limit for medical devices that come into contact with cerebrospinal fluid. Exposure to endotoxins can cause an acute inflammatory process.

This recall affects 167 units distributed nationwide in the United States (including UT, AL, CA, NC, GA, AR, LA, KY, IL, and OK) and in Costa Rica. The affected lot is 2025-08779.

The recalled product

Product
Ventriculostomy Kit, REF: 46154
Manufacturer
Medtronic Neurosurgery
Category
Medical Device — Neurosurgical Equipment
Hazard
  • endotoxin
  • inflammation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 00673978947396
  • Lot: 2025-08779

Distribution

Distributed nationwide across the United States.

Related recalls

Same category