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OSV II Valve System

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 9OS1000 · UDI-DI 10381780035992

JXG Prescription
10
510(k) clearances
25,592
Adverse events (226 deaths)
108
Recalls
70
Facilities

Description

The OSV II Hydrocephalus Valve System is an implantable device for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, the OSV II Valve System is a varable resistnace valve which maintains a dreanage rate close to the CSF secretion rate (20 ml/hr) within the physioligical range of intracranial of pressure. 2

Recalls

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