FDA recall Z-2768-2026

Medtronic Neurosurgery · Class II · device

Product

Ventriculostomy Kit, REF: 46154

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.

Key facts

Status
Ongoing
Initiation date
2026-06-17
Report date
2026-07-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Haltom City, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2768-2026