Ventriculostomy Kit, REF: 46154
FDA device recall Z-2768-2026 · posted 2026-07-21 · Open, Classified
Recall details
- Recalling firm
- Medtronic Neurosurgery
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBG
- Quantity affected
- 167
- 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.
- Date initiated
- 2026-06-17
- Date posted
- 2026-07-21
- Location
- Haltom City, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PS MEDICAL VENTRICULOSTOMY KIT (K915546) | Pudenz-Schulte Medical Research Corp. | 1991-12-30 |