BEUDAMED
    FDA Enforcement Class I Terminated

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    Recall: Z-1462-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1462-2015
    Event ID
    70853
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laax, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 25, 2015
    Classification Date
    April 23, 2015
    Termination Date
    March 17, 2017
    Address
    151 Lindbergh Ave Ste I, Livermore, CA, 94551-9497, United States

    Description

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    Reason

    Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

    Code Info

    Part number C-TP-1509 (9 connector) All serial numbers/lots

    Distribution

    Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    ~4,154 units distributed in US - both part numbers