Medtronic Neurosurgery recalls Ventriculostomy Kit REF 461: endotoxin levels may exceed safe limits for cerebrospinal fluid contact, causing inflammation. Affected units sold with UDI-DI 00673978947396 and Lot 2025-08779.
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.
Medtronic Neurosurgery is recalling Ventriculostomy Kits with reference number 46154 due to potential endotoxin levels that could cause inflammation when used in cerebrospinal fluid. This risk applies to medical procedures where the device contacts cerebrospinal fluid.
The Ventriculostomy Kit may have endotoxin levels higher than acceptable for devices that contact cerebrospinal fluid. This can trigger an acute inflammatory response in the body, potentially causing complications during medical procedures.
Healthcare professionals using the Ventriculostomy Kit during neurosurgery procedures are most at risk. Patients receiving the device during surgery may also be affected if the endotoxin levels exceed safe limits.
Check for the reference number 46154 on the kit. Affected units include those with UDI-DI 00673978947396 and Lot number 2025-08779.
Verify the reference number 46154 and UDI-DI 00673978947396 with lot number 2025-08779.
The recall is for medical devices used during procedures. Endotoxin exposure could cause inflammation, but the risk is specific to the procedure context.
Check for reference number 46154, UDI-DI 00673978947396, and lot number 2025-08779 on the kit.
The recall does not specify a remedy, so contact Medtronic Neurosurgery directly for guidance.
We’ve drafted a message you can send Medtr: Neurosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-2768-2026 — Medtr: Neurosurgery Medtr: Neurosurgery Hello, I own a Medtr: Neurosurgery that is covered by recall Z-2768-2026 from Medtr: Neurosurgery. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
