FDA Medical Device Recalls (openFDA)
Medtronic Neurosurgery: Ventriculostomy Kit, REF: 46154
- Recall number
- Z-2768-2026
- Recalling firm
- Medtronic Neurosurgery
- Product
- Ventriculostomy Kit, REF: 46154
- Status
- Open, Classified
- Initiated
- 2026-06-17
- Posted
- 2026-07-21
- Terminated
- not on file
- 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.
- Root cause
- Process control
- 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
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 00673978947396, Lot: 2025-08779
- 510(k) numbers
- ["K915546"]
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 3015531529
- Firm city
- Haltom City
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28