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Integra DP Valve System

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 907142 · UDI-DI 10381780033554

JXG Prescription
2
510(k) clearances
25,520
Adverse events (222 deaths)
108
Recalls
70
Facilities

Description

Integra DP Valve System is an implantable device which serves as a parallel flow pathway to divert cerebrospinal fluid (CSF) from the cerebral ventricles to an appropriate drainage site (differential pressure valve). It provides controlled intraventricular pressure and CSF drainage in patients with hydrocephalus or other conditions in which CSF flow and/or absorption is impaired.

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 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.
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.