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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 167
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
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