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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of 167 Medtronic Neurosurgery Ventriculostomy Kits Over Endotoxin Levels

An FDA enforcement report lists an ongoing recall, initiated 17 June 2026, of a single lot of a sterile neurosurgical drainage kit distributed in 12 listed US states and Costa Rica.

By AI ReporterUpdated Aug 7, 2026, 10:29 a.m. ET
An FDA enforcement report, recall number , records an recall by of 167 units of a . The record lists the recall as initiated on 17 June 2026 and reported on 29 July 2026, and identifies the affected product by UDI-DI 00673978947396 and lot 2025-08779. The action is listed as still , so details may change. According to the FDA record, the reason given is that the 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; the record states that endotoxin exposure can cause an acute inflammatory process. The report gives distribution as "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" — the state list as written in the record repeats LA and KY. The kit is not a consumer product. Reference listings in the FDA's Global Unique Device Identification Database, published via AccessGUDID, describe catalogue number 46154 under the brand name "Ventriculostomy Kit - European" as a sterile, single-use neurosurgical set supplied one per package. Published clinical references describe ventriculostomy as the surgical placement of a thin catheter through a small hole drilled in the skull into the brain's fluid-filled ventricles so cerebrospinal fluid can drain through an external tube; such kits bundle the disposable items for one procedure — typically a radiopaque silicone catheter with a stiffening stylet, connectors, a stopcock, tubing and a drainage assembly. They are sold per unit to hospitals, neurosurgical departments and intensive-care units through medical-device distributors and handled only by clinical staff. This background describes the product generally and says nothing about the recall. The FDA classified the recall as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:29current

    No new facts; added headline and dek and confirmed all figures against the FDA enforcement record.

  2. Version 57 Aug 2026, 10:16

    Added a sourced paragraph describing what the ventriculostomy kit is and who uses it, from GUDID and clinical reference sources.

  3. Version 47 Aug 2026, 06:35

    Removed device-description and distribution-channel material that is not in the current fact set; added citation for the FDA's Class II definition.

  4. Version 37 Aug 2026, 00:49

    Replaced the patent-derived device description with the GUDID listing and reference-work definition, and quoted the record's distribution string verbatim including its repeated LA and KY entries.

  5. Version 26 Aug 2026, 20:16

    Replaced the unsourced GUDID product description with the cited background research on what a ventriculostomy kit contains and how it is used, and added the supporting reference URLs.

  6. Version 16 Aug 2026, 15:35

    First published.

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