Medtronic Neurosurgery: Ventriculostomy Kit, REF: 46154

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 167 Lot/code info: UDI-DI: 00673978947396, Lot: 2025-08779

UPC codes

00673978947396

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.