Recall Z-2768-2026— Medtronic Neurosurgery

Name: FDA recall Z-2768-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-17

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2026-06-17. It names one FDA 510(k) clearance: K915546. Product: Ventriculostomy Kit, REF: 46154. Reason: 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..

Recalling firm: Medtronic Neurosurgery
Classification: Class II
Status: Ongoing
Initiated: 2026-06-17
Firm location: Haltom City, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K915546 — PS MEDICAL VENTRICULOSTOMY KITPudenz-Schulte Medical Research Corp.·cleared 1991-12-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.