Medical Device Recall: Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute is
Scientia Vascular, Inc. · January 2, 2025
Reason for Recall
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.
Product Description
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Distribution
U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.
States Affected
NATIONWIDE
Quantity Affected
120 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1234-2025
Status: ongoing
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