Medtronic Neurosurgery: Drills, Burrs, Trephines & Accessories (manual)
Recall Summary Medtronic is recalling Ventriculostomy Kits (REF: 46154) used in brain surgery to access fluid spaces in the brain. The kits may contain higher-than-acceptable levels of endotoxin, a bacterial substance that can trigger inflammation when it contacts the cerebrospinal fluid. The recall affects devices distributed nationwide in the US and Costa Rica.
- Recalling firm
- Medtronic Neurosurgery
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/b26d9501-1957-4d5e-9e9d-baa8d41fd23f