BEUDAMED
    FDA Enforcement Class III Terminated

    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

    Recall: Z-0617-2013 · Reported January 9, 2013

    Enforcement

    Recall Number
    Z-0617-2013
    Event ID
    63855
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 9, 2013
    Initiation Date
    March 28, 2012
    Classification Date
    December 28, 2012
    Termination Date
    July 12, 2013
    Address
    177 E County Road B, N/A, Saint Paul, MN, 55117-1951, United States

    Description

    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

    Reason

    St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.

    Code Info

    Model no. 406586 Batch no. 3619533

    Distribution

    US Distribution only including the states of FL, KY and OK.

    Quantity

    26