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Ventriculostomy Kit - European

MEDTRONIC PS MEDICAL, INC. · Model 46154 · UDI-DI 00673978947396

HBG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

KIT 46154 VNTRC EURO

Recalls

Date	Firm	Reason
2026-06-17	Medtronic Neurosurgery	Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices
2024-04-17	Integra LifeSciences Corp.	Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
2024-01-19	Integra LifeSciences Corp.	A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.