Device, Monitoring, Intracranial Pressure

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Customer complaints of Pressio monitor rebooting.

Codman Microsensor Basic Kit. Catalog Number: 626631US.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Becker External Drainage and Monitoring System:

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Exacta External Drainage and Monitoring System:

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO

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 infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.

The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature wit

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 infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.

CereLink ICP Extension Cable (Extension Cable), Model No. 826845

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.