BEUDAMED
    FDA Recall Terminated

    WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

    Recall: Z-0394-2022 · Initiated November 22, 2021

    Recall

    Recall Number
    Z-0394-2022
    Event Number
    89120
    Firm
    Cardiovascular Systems Inc
    FEI Number
    3004742232
    Product Code
    NTE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 22, 2021
    Posted
    December 21, 2021
    Terminated
    August 31, 2023
    Address
    1225 Old Highway 8 NW, Saint Paul, MN, 55112-6416

    Description

    WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6

    Reason

    Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.

    Action

    Consignees were issued an URGENT: Medical Device Recall letter dated 11/22/2021. Consignees are asked to immediately remove from use and return affected devices to CSI. To do so: 1) Complete the attached Customer Acknowledgement Form. a) Per lot, document the quantity of all devices that are to be returned. b) Per lot, document the quantity of all devices that have been consumed. 2) Place the Acknowledgement Form with the device. 3) Return the device and Acknowledgement Form to CSI using the pre-paid label. A CSI Sales representative can return the device and form. Please contact CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgement Form per the above, and return the form to CSI in the provided envelope. For further info, please contact: Cardiovascular Systems, Inc. Field Action Hotline [email protected] 651-259-2800

    Distribution

    United States- AK, AL, AR, AZ, CA, DC, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV OUS - Netherlands

    Quantity

    711 units