BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 19, 2025

    Recall

    Recall Number
    Z-1396-2025
    Event Number
    96340
    Firm
    Calyxo, Inc.
    FEI Number
    3014683069
    Product Code
    FED
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    February 19, 2025
    Posted
    March 21, 2025
    Address
    4473 Willow Rd, Pleasanton, CA, 94588-8571

    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.

    Action

    On 2/19/2025, correction notices were mailed to distributors and healthcare providers who were asked to do the following: 1) Notify all urologists utilizing the affected aspiration system in your institution that additional instructions are required. Please provide each of them with a copy of the additional instructions. 2) As another safety step, a firm representative will be contacting all users from your institution directly to offer training on these additional instructions. If you prefer to coordinate the training, please specifically state that preference in the acknowledgement. 3) Please acknowledge receipt of the notice, additional instructions, and updated training instructions MA00100.A by emailing [email protected], or calling 833-214-3354 and providing your name, title, institution and address.

    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