Z-2768-2026Class II

Ventriculostomy Kit, REF: 46154

Name: Z-2768-2026 Ventriculostomy Kit, REF: 46154
Creator: Medtronic Neurosurgery
Published: 2026-06-17
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2026-06-17 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Neurosurgery began a recall of Ventriculostomy Kit, REF: 46154 on 2026-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2768-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-17
Posted: 2026-07-21
Recalling firm: Medtronic Neurosurgery
Product: Ventriculostomy Kit, REF: 46154
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00673978947396, Lot: 2025-08779

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2768-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2768-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-21

Product code HBG

K915546Class IIPs Medical Ventriculostomy KitPudenz-Schulte Medical Research Corp. / cleared 1991-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)