BEUDAMED
    FDA Recall Terminated

    St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA

    Recall: Z-1780-2010 · Initiated June 15, 2009

    Recall

    Recall Number
    Z-1780-2010
    Event Number
    53611
    Firm
    St. Jude Medical Atrial Fibrillation Division Inc
    FEI Number
    2938836
    Product Code
    OCL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 15, 2009
    Posted
    June 7, 2010
    Terminated
    March 2, 2012
    Address
    240 Santa Ana Ct, Sunnyvale, CA, 94085-4512

    Description

    St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA

    Reason

    The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has

    Action

    St. Jude Medical issued a Market Bulletin, dated 06/15/2009, to their Field Representatives who were instructed to contact customers to make them aware that changes were made to the Instructions for Use (IFU) by SJM and that the customer may notice an extra IFU included in the shipping package. All such worldwide regulatory approvals will be needed before a revised IFU can eventually be included directly within the device package (as opposed to the shipping box). Existing instructional materials including the Epicor LP System Set-up ACS hang sheet and the EpicorLP In-service slides are being revised to reflect the UltraWand LP IFU changes The forthcoming Epicor LP In-service video is also being updated to reflect these changes. An Important Medical Device Safety Information letter, dated 11/06/2009 was sent via FedEx beginning 11/10/2009 to all US customers and will also shipped to all OUS customers beginning 11/13/2009. A copy of the new IFU will be sent with the letter which is being sent to all customers that have purchased or consigned the SJM UltraWand LP product since its commercial release in July of 2008. The customer notification includes the SJM Marketing managers and director for questions on the action.

    Distribution

    AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. OUS to include Australia, Canada, Japan, Korea, Singapore

    Quantity

    1813 (1155 US, 658 OUS)