Z-2768-2026 Class II Ongoing
FDA device recall Z-2768-2026 was initiated by Medtronic Neurosurgery on June 17, 2026 and is designated Class II. 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 conta… The recall status is ongoing. Affected quantity: 167.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 17, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167
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.
Distribution Pattern
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.
Code Information
UDI-DI: 00673978947396, Lot: 2025-08779