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Intraventricular Monitoring Catheter Set

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 910130A · UDI-DI 10381780035596

JXG Prescription

510(k) clearances

25,418

Adverse events (222 deaths)

108

Recalls

Facilities

Description

The Intraventricular Monitoring Catheter Set (IVMCS) contains: a 35 cm Radiopaque Ventricular Catheter with large holes and graphite length marks at 5, 10, 15 cm from the tip; a Catheter passer with barbed end; a F8 Luer lock connector; a 35 cm introducer; a 20 cm introducer; a Slit suture clamp; a Watertight cap; a T-Connector/Stopcock Assembly (male Luer lock T-Connector with self-sealing injection/sampling port, drainage tube, four-way stopcock with two female Luer Lock outlet connectors, and watertight cap).

Recalls

Date	Firm	Reason
2026-04-10	Integra LifeSciences Corp. (NeuroSciences)	Out-of-specification endotoxin result that did not meet the acceptance criteria.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-12-16	Integra LifeSciences Corp.	Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2024-05-07	Integra LifeSciences Corp.	Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-11-28	Natus Medical Incorporated	Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
2023-06-28	Medtronic Neurosurgery	Product labeling contains incorrect expiration date

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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.