BEUDAMED
    FDA Enforcement Class II Ongoing

    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

    Recall: Z-1234-2025 · Reported March 5, 2025

    Enforcement

    Recall Number
    Z-1234-2025
    Event ID
    96158
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Scientia Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2025
    Initiation Date
    January 2, 2025
    Classification Date
    February 26, 2025
    Address
    2460 S 3270 W, N/A, West Valley City, UT, 84119-1116, United States

    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

    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.

    Code Info

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

    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.

    Quantity

    120 devices