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Contour-Flex Valve and Shunt System
INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model CFRH · UDI-DI 10381780036784
JXG
Prescription
10
510(k) clearances
25,592
Adverse events (226 deaths)
108
Recalls
70
Facilities
Description
The Integra Contour-Flex Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Contour-Flex Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The Contour-Flex Valve is available in two sizes: Regular and Small. Both sizes are available in 3 pressure/flow characteristics ranges: low, medium, and high.
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 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 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. |
| 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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Get your free API keyRead the docsData 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.