| | Class 2 Device Recall Ventriculostomy Kit |  |
| Date Initiated by Firm | June 17, 2026 |
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| Date Posted | July 21, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2768-2026 |
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| Recall Event ID |
99342 |
| 510(K)Number | K915546 |
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| Product Classification |
Drills, burrs, trephines & accessories (manual) - Product Code HBG
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| Product | Ventriculostomy Kit, REF: 46154 |
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| Code Information |
UDI-DI: 00673978947396, Lot: 2025-08779 |
| FEI Number |
3015531529
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Recalling Firm/
Manufacturer |
Medtronic Neurosurgery
4620 N Beach St
Haltom City TX 76137-3219
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| For Additional Information Contact | Christine Stewart
269-377-2557 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| Action | 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 |
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| Quantity in Commerce | 167 |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HBG
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