Recall Z-2768-2026 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Medtronic Neurosurgery
Ventriculostomy Kit, REF: 46154
| Date | Jul 21, 2026 (initiated Jun 17, 2026) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915546 | PS MEDICAL VENTRICULOSTOMY KIT Pudenz-Schulte Medical Research Corp., Dec 30, 1991 |