BEUDAMED
    FDA Enforcement Class I Ongoing

    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

    Recall: Z-1396-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1396-2025
    Event ID
    96340
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Calyxo, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2025
    Initiation Date
    February 19, 2025
    Classification Date
    March 21, 2025
    Address
    4473 Willow Rd, N/A, Pleasanton, CA, 94588-8571, United States

    Description

    CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

    Reason

    Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.

    Code Info

    CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C

    Distribution

    US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.

    Quantity

    11,246