Medtronic Neurosurgery recalls Ventriculostomy Kit

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.

On 6/17/2026, recall notices were mailed and emailed to customers asking them to do the following: 1) Identify, quarantine, and return affected devices to the firm. 2) Complete and return the Customer Confirmation Form via email to neuro.quality@medtronic.com 3) This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. For additional information, email the firm at rs.mnsprodexperiencehelp@medtronic.com

• FDA enforcement recordOfficial FDA database entry for Z-2768-2026
• FDA 510(k) clearance · K915546The device's official FDA premarket clearance record
• FDA device classification · HBGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic NeurosurgerySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.