Ventriculostomy Kit, REF: 46154 recallZ-2768-2026 · Medtronic Neurosurgery · initiated Jun 17, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] 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 [email protected]
Recall details
- Recall number
- Z-2768-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 17, 2026
- Posted by the FDA
- Jul 21, 2026
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 167
- Product code
- HBG
- FDA submissions
- K915546
- 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.
Product description
Ventriculostomy Kit, REF: 46154
Code information (models, lots, serial numbers)
UDI-DI: 00673978947396, Lot: 2025-08779
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ventriculostomy Kit - European 46154Medtronic Ps Medical, Inc. · DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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