Home / Recalls / Scientia Vascular, Inc. / Z-1234-2025

Z-1234-2025 Class II Ongoing

Recalled by Scientia Vascular, Inc. — West Valley City, UT

Recall Details

Product Type: Devices
Report Date: March 5, 2025
Initiation Date: January 2, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 120 devices

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

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.

Distribution Pattern

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.

Code Information

Catalog Number: SC038-127-001 UDI-DI code: 00818075011025 Lot Numbers: 030471 030317 030345 030376 030427 030451