BEUDAMED
    FDA Recall Open, Classified

    Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95

    Recall: Z-1512-2025 · Initiated February 26, 2025

    Recall

    Recall Number
    Z-1512-2025
    Event Number
    96492
    Firm
    Qapel Medical Inc.
    FEI Number
    3020954126
    Product Code
    NRY
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 26, 2025
    Posted
    April 7, 2025
    Address
    4245 Technology Dr, Fremont, CA, 94538-6339

    Description

    Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95

    Reason

    Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

    Action

    On 2/26/2025, removal and discontinuation notices were mailed to customers were asked to do the following: 1) Quarantine affected devices and return to the firm. 2) If you have provided this product to others, let the firm know so they can notify them of this action and retrieve any remaining product. 3) Complete and return the Acknowledgement and Response Card via email to [email protected] If you have any questions regarding this letter, please contact customer service for further information at [email protected], or by phone at 510-738-6255 between the hours of 8am - 5pm PST.

    Distribution

    US: CA, IL, NE, TN, TX, NJ, NC, SD, FL, MI, PA, GA, AL, IN, NY, WI, AZ, MN, LA, OH, OK, SC, NV, ND, ID, MO, CT, WA, MA. OUS: QATAR, United Arab Emirates, Republic of Kazakhstan

    Quantity

    1617