Sophysa recalls specific models of intracranial pressure monitoring kits due to potential cerebrospinal fluid leakage during implantation, which could lead to infection. Affected units have serial numbers listed in the recall notice.
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.
Sophysa is recalling certain intracranial pressure monitoring kits that may leak cerebrospinal fluid (CSF) during implantation, creating an infection risk. The issue stems from a manufacturing error causing the catheter to perforate during stylet insertion.
The catheter's inner channel can perforate during stylet insertion due to a manufacturing error, leading to undetected CSF leakage. If not caught, this could introduce infection into the patient's system.
Patients who have received the recalled intracranial pressure monitoring kits for cerebrospinal fluid drainage are at risk. Medical professionals using these kits during implantation procedures should also be aware.
Check if your kit has a serial number starting with '22D' or '23D' followed by numbers as listed in the recall notice. The product is intended for intracranial pressure monitoring and cerebrospinal fluid drainage.
Look for the serial number on the kit, which begins with '22D' or '23D' followed by numbers as listed in the recall notice.
Reach out to Sophysa directly to confirm if your specific model is affected and to get instructions for next steps.
The recalled product is the Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit (PSO-VTT) with specific serial numbers listed in the recall notice.
Check if your kit has a serial number starting with '22D' or '23D' followed by numbers as listed in the recall notice.
The recall indicates a potential risk of infection due to undetected CSF leakage, but the hazard does not specify immediate serious injury in normal use.
We’ve drafted a message you can send Sophysa to request your refund or repair — edit it as you like.
Subject: Recall Z-1826-2024 — Sophysa Sophysa Hello, I own a Sophysa that is covered by recall Z-1826-2024 from Sophysa. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
