- 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.
- Affected products (lot / model / serial)
- UDI-DI: 00673978947396, Lot: 2025-08779
- Units affected
- 167
- 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.
- Firm location
- Haltom City, TX, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2768-2026
- Recall initiated
- June 17, 2026
- FDA classification date
- July 21, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99342
- Last updated on HTM Vibe
- August 4, 2026