FDA Device recall Z-2768-2026
Ventriculostomy Kit, REF: 46154
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Ventriculostomy Kit, REF: 46154 by Medtronic Neurosurgery, citing ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2768-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-17 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
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.
Identifiers
| code_info | UDI-DI: 00673978947396, Lot: 2025-08779 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
All Medtronic Neurosurgery recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2768-2026%22
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