BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated January 2, 2025

    Recall

    Recall Number
    Z-1234-2025
    Event Number
    96158
    Firm
    Scientia Vascular, Inc.
    FEI Number
    3009546466
    Product Code
    NRY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 2, 2025
    Posted
    February 26, 2025
    Address
    2460 S 3270 W, West Valley City, UT, 84119-1116

    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.

    Action

    On 01/02/2025, the firm initially notified customer via email an "URGENT: MEDICAL DEVICE RECALL" Letter informing them that through internal evaluation of finished goods of the Socrates 38 Aspiration Catheter, one lot of pouches containing the 127 cm Socrates 38 Aspiration Catheter was identified with pouches that had a gap in the sterile barrier seal. This was a result of the pouch not being centered with the sealing bar during the sealing process. On 01/10/2025, The firm sent an updated letter informing customers of additional product lots were added to the Recall. Customers are instructed to: Segregate Recalled Product. Immediately remove all impacted (see list above) Socrates 38 Catheter(s) from their inventory (regardless of its location) and segregate this product in a secure location for return to Scientia Vascular, Inc. In situations where a device has already been used in a patient procedure, closely monitor patients for signs and symptoms of post-surgical infection. Customer Service will be available to provide additional information and provide replacement orders at [email protected] or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.

    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