BEUDAMED
    FDA Recall Terminated

    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.

    Recall: Z-0576-2020 · Initiated December 7, 2018

    Recall

    Recall Number
    Z-0576-2020
    Event Number
    84057
    Firm
    Spectranetics Corporation
    FEI Number
    3005462046
    Product Code
    NWX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 7, 2018
    Terminated
    October 27, 2020
    Address
    5055 Brandin Ct, Fremont, CA, 94538-3140

    Description

    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.

    Reason

    The incorrect outer carton box was used for the product.

    Action

    The recalling firm issued an undated Dear Healthcare Professional letter via FedEx informing the consignee of the issue, the risk to health, and the actions to be taken. Return of the device was requested.

    Distribution

    Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.

    Quantity

    3 catheters