BEUDAMED
    FDA Enforcement Class II Terminated

    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.

    Recall: Z-0900-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0900-2014
    Event ID
    67298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    January 6, 2014
    Classification Date
    January 30, 2014
    Termination Date
    October 29, 2014
    Address
    47215 Lakeview Blvd, Fremont, CA, 94538-6530, United States

    Description

    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.

    Reason

    Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.

    Code Info

    Product number: H749364560, Catalog number: 36456; Lot numbers: 16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014.

    Distribution

    US Nationwide Distribution and Mexico

    Quantity

    1068 single units