BEUDAMED
    FDA Recall Terminated

    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.

    Recall: Z-2178-2010 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-2178-2010
    Event Number
    56222
    Firm
    St. Jude Medical Cardiovascular Division
    FEI Number
    2182269
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 28, 2010
    Posted
    August 12, 2010
    Terminated
    December 27, 2011
    Address
    14901 Deveau Pl, Minnetonka, MN, 55345

    Description

    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.

    Reason

    Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief.

    Action

    Consignees were sent "Urgent Medical Device Recall Notice" dated June 24, 2010 from St. Jude Medical . The letter was addressed to Cath Lab Manger/ Risk Manager. The letter described the problem and the product involved. Advised consignees to discontinue use of the product and remove from inventory. Sales Representatives were also sent a St. Jude Medical Memorandum "Field Action Notice" dated June 24, 2010 and a reconciliation form. The memorandum described the problem and product. Advised Sales Rep to visit the affected accounts and to performed the assigned tasks. A St. Jude Medical sales representative will be contacting for removal and replacement of the affected product. For additional information, please contact St. Jude Medical at 651-491-4470.

    Distribution

    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.

    Quantity

    5 OUS