Sophysa S.A.: Pressio Ventricular Monitoring Kits Recalled for Catheter Leakage

What You Should Do

1. Identify if you have the Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit by checking the packaging for Model/Catalog Numbers PSO-VT or PSO-VTT.
2. Check the serial numbers on your device against the extensive list of affected units, which includes 3,487 units of model PSO-VT (UDI-DI 03760124131482) and 3,175 units of model PSO-VTT (UDI-DI 3760124132922).
3. Verify if your unit is part of the specific U.S. distribution, particularly if you are located in Arizona, New York, or Texas, where 41 units of model PSO-VTT were distributed.
4. Immediately stop using any affected kits that have not yet been implanted and quarantine them to prevent surgical use.
5. Contact your healthcare provider or the manufacturer, Sophysa S.A., to discuss the risks if you or a patient has already received an implant from an affected lot.
6. Follow the manufacturer's specific instructions for returning the recalled kits and obtaining a replacement or further technical guidance.
7. For additional questions, contact the FDA at 1-888-463-6332 or visit the official medical device recall website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products