BEUDAMED
    FDA Recall 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 · Initiated March 25, 2015

    Recall

    Recall Number
    Z-1462-2015
    Event Number
    70853
    Firm
    Laax, Inc.
    FEI Number
    3008788191
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    March 25, 2015
    Posted
    April 23, 2015
    Terminated
    March 17, 2017
    Address
    151 Lindbergh Ave, Ste I, Livermore, CA, 94551-9497

    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.

    Action

    The firm, LAAx, Inc.on behalf of Maquet Medical Systems, sent an "URGENT MEDICAL DEVICE RECALL (Removal) IMMEDIATE ACTION REQUIRED " letter dated March 30, 2015 to all affected sites by express mail. The letter describers the product, problem and actions to be taken. The customers were instructed to examine your inventory immediately to determine if you have any TIGERPAW System II products; remove the products, quarantine them and place in a secure location; complete and return the MEDICAL DEVICE RECALL (Removal) RESPONSE FORM by e-mailing a scanned copy to:[email protected] or FAX to: 1-(973)-396-3607. If you have acted as a distributor for the TIGERPAW System product II, immediately contact those accounts, advise them of the recall situationa and have them return all stock to you. Your Marquet Medical System USA Sales Representative will contact you to assist with the return of any product. If you have any additional questions, contact your local Maquet Medical Systems USA Sales Representative or our Customer Service at 1-888-880-2874 (6:00 AM - 5:00 PM PST).

    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