Scientia Vascular recalls Socrates 38 Aspiration Catheter 127cm (REF SC038-127-001) due to packaging seal channels risking sterile barrier breaches. Affected units include specific lot numbers from 2023.
Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Scientia Vascular is recalling its Socrates 38 Aspiration Catheter (127 cm length, REF SC038-127-001) because manufacturing flaws in the packaging seal could create breaches in the sterile barrier. This poses a risk of contamination during medical procedures, potentially leading to infections or other complications for patients.
The packaging seal has manufacturing defects that create channels, which could compromise the sterile barrier. This might allow contaminants to enter the sterile system during medical procedures, increasing infection risk.
Healthcare professionals using the Socrates Aspiration System for acute ischemic stroke treatment are most at risk. Patients receiving this procedure may be affected if the catheter is used on contaminated equipment.
Check for the product reference SC038-127-001 on the packaging. Affected units include specific lot numbers: 030471, 030317, 030345, 030376, 030427, 030451.
Verify the product reference SC038-127-001 and lot numbers on the packaging to confirm if your item is affected.
The product is not safe for use as recalled due to packaging seal defects that could compromise sterility.
The recall does not specify a remedy, so contact the manufacturer for guidance on next steps.
Affected lot numbers are 030471, 030317, 030345, 030376, 030427, 030451.
We’ve drafted a message you can send Scientia Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2025 — Scientia Vascular Scientia Vascular Hello, I own a Scientia Vascular that is covered by recall Z-1234-2025 from Scientia Vascular. 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.
