Sophysa S.A. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranialClass IIApr 9, 2024An increase in claims related to leakage of cerebrospinal fl	An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. I	Class IIDevices	Apr 9, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranialClass IIApr 9, 2024An increase in claims related to leakage of cerebrospinal fl	An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. I	Class IIDevices	Apr 9, 2024