United StatesThe Ventriculostomy Kit (REF 46154, UDI‑DI 00673978947396, Lot 2025-08779) sold by Medtronic Neurosurgery and distributed in the U.S. and Costa Rica is being recalled. The devices may have endotoxin levels exceeding the acceptable limit for products that contact cerebrospinal fluid, and endotoxin exposure can cause an acute inflammatory process.
What's being recalled
Ventriculostomy Kit, REF: 46154
Recalling firm: Medtronic Neurosurgery, Haltom City, TX, United States.
How to identify it
UDI-DI: 00673978947396, Lot: 2025-08779
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)