BEUDAMED
    FDA Recall Terminated

    Pacific Xtreme (PTCA Balloon Dilation Catheter)

    Recall: Z-3055-2020 · Initiated August 26, 2020

    Recall

    Recall Number
    Z-3055-2020
    Event Number
    86393
    FEI Number
    2183870
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 26, 2020
    Terminated
    June 9, 2023
    Address
    ev3 Inc. 4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

    Pacific Xtreme (PTCA Balloon Dilation Catheter)

    Reason

    Labeling discrepancy for the Rated Burst Pressure (RBP) value.

    Action

    On August 26th 2020 the firm send its consignees a letter. Customer Instructions: Medtronic records indicate that your facility has received one or more of the listed Pacific Xtreme PTA Balloon Catheter. As a result, Medtronic requests that you immediately take the following actions: 1.Identify and quarantine all affected and unused Pacific Xtreme PTA Balloon Catheters as listed in the enclosed Customer Notification Detail Report. 2.Return/Exchange all affected and unused Pacific Xtreme PTA Balloon Catheters in your inventory to Medtronic.Contact Medtronic Customer Service at 800-716-6700 to initiate a product return/exchange. Your local Medtronic Representative can assist you as necessary in initiating the return of this product. 3.Complete the enclosed Customer Confirmation Form and email to [email protected]

    Distribution

    Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.

    Quantity

    4286 devices