fda
3 records
FDA Recall: Sophysa S.A. — Class II
20240522
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected d | Product: The Sophysa Pressio¿ Ventricular Intra...
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FDA Device Recall: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring
2024-05-22
Class II — An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an in...
View Source
FDA Device Recall: The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring
2024-05-22
Class II — An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an in...
View Source
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