Sophysa recalls specific models of ventricular pressure monitoring kits due to potential cerebrospinal fluid (CSF) leakage during implantation, which could lead to infection. Affected units have serial numbers listed in the recall.
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 ventricular pressure monitoring kits that may leak cerebrospinal fluid (CSF) during implantation. This could lead to an infectious risk for patients if undetected. The issue is caused by a manufacturing error in the catheter's inner channel.
The catheter's inner channel can become perforated during stylet insertion, causing cerebrospinal fluid (CSF) to leak. If the leak goes undetected during implantation, it could introduce infection into the patient's system.
Patients who have received the recalled ventricular pressure monitoring kits for intracranial pressure monitoring. The risk is primarily for those with the specific serial numbers listed in the recall.
Check if your kit has the model PSO-VT and serial numbers listed in the recall (e.g., 22C02558, 22C02582, etc.). The recall includes a specific list of serial numbers.
Verify if your ventricular pressure monitoring kit has the model PSO-VT and one of the listed serial numbers.
The risk is that the catheter may leak cerebrospinal fluid (CSF) during implantation, which could lead to an infectious risk if undetected. This is caused by a manufacturing error in the catheter's inner channel.
Check if your kit has the model PSO-VT and a serial number listed in the recall (e.g., 22C02558, 22C02582, etc.). The full list of affected serial numbers is provided in the recall.
Yes, if your kit is affected, you should contact Sophysa to confirm the issue and follow their instructions. However, the risk is low as the leak is unlikely to be detected during implantation.
We’ve drafted a message you can send Sophysa to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2024 — Sophysa Sophysa Hello, I own a Sophysa that is covered by recall Z-1825-2024 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.
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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.
