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Polypropylene Connector
INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 999412 · UDI-DI 10381780034643
JXG
Prescription
1
510(k) clearances
25,520
Adverse events (222 deaths)
108
Recalls
70
Facilities
Description
Connectors are implantable accessories intended to be used with Integra hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
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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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.