BEUDAMED
    FDA Enforcement Class II 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 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0576-2020
    Event ID
    84057
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spectranetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2019
    Initiation Date
    December 7, 2018
    Classification Date
    November 26, 2019
    Termination Date
    October 27, 2020
    Address
    5055 Brandin Ct, Fremont, CA, 94538-3140, United States

    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.

    Code Info

    AngioSculpt PTCA lot #G18090030.

    Distribution

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

    Quantity

    3 catheters