Summary
The FDA issued a Class II for Ventriculostomy Kit, REF: 46154 by Medtronic Neurosurgery. Reason: Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the.
Details
Source
Device Recall
External ID
Z-2768-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
Ventriculostomy Kit, REF: 46154
Lot/Code Info: UDI-DI: 00673978947396, Lot: 2025-08779
Quantity Affected: 167
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Haltom City, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Medtronic Neurosurgery has 13 FDA actions in our database, including 10 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neurosurgery) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neurosurgery have FDA actions?
Medtronic Neurosurgery has 13 FDA actions in our database, including 10 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2768-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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