BEUDAMED
    FDA Recall Terminated

    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

    Recall: Z-0935-2008 · Initiated November 20, 2007

    Recall

    Recall Number
    Z-0935-2008
    Event Number
    45903
    Firm
    Boston Scientific
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    November 20, 2007
    Posted
    January 31, 2008
    Terminated
    October 23, 2008
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

    Reason

    Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.

    Action

    The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****

    Distribution

    Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.

    Quantity

    211 single units