BEUDAMED
    FDA Recall Terminated

    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.

    Recall: Z-0384-2007 · Initiated December 13, 2006

    Recall

    Recall Number
    Z-0384-2007
    Event Number
    37001
    Firm
    Boston Scientific
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 13, 2006
    Posted
    February 7, 2007
    Terminated
    June 28, 2007
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.

    Reason

    Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.

    Action

    An Urgent Medical Device Recall letter, dated 12/13/06, and a Clarification of Recall Notification letter, dated 12/14/06, were sent to all affected hospitals. The letter describes the issue, affected product, asks for customers to discontinue further distribution or use of any remaining product and asks for product to be returned. Replacement product will be available for any/all returned product.

    Distribution

    Nationwide.

    Quantity

    7